PreDiabetesTELE-GENNCT04618458
Telehealth Diabetes Prevention Intervention for African American Youth
A study testing Power to Prevent in people with PreDiabetes and Obesity, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
The Telehealth Diabetes Prevention Intervention for the Next Generation of African American Youth (TELE-GEN) pilot study will evaluate the implementation and early efficacy of a telehealth diabetes prevention intervention for African American (AA) children (8- to 11-years) and their parents. Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- PreDiabetes, Obesity, Obesity, Childhood
- What is being tested?
- Power to Prevent
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 18 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- AA parents (biological, grandparent, legal guardian) and their 8- to 11-year-old child residing in the same home.
- One overweight/obese parent (BMI ≥25 kg/m2) and child (≥ 85th% age-/sex-specific BMI).
- Parent at-risk for diabetes (American Diabetes Association risk test) AND HbA1c 5.7% - 6.4%.
Who cannot join
- child or parent has a history of T2DM or a screening HbA1c >6.4%;
- is taking glucose-lowering medications;
- is participating in a supervised weight loss program;
- is pregnant or breast feeding;
- has conditions limiting participation;
- has undergone weight loss surgery;
- is moving out-of-state within 6 months.
- If a parent becomes pregnant during the study, we will include only child data (index participant) in analyses
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Official title: A Telehealth Diabetes Prevention Intervention for the Next Generation of African American Youth (TELE-GEN) Pilot Study
The Telehealth Diabetes Prevention Intervention for the Next Generation of African American Youth (TELE-GEN) pilot study will evaluate the implementation and early efficacy of a telehealth diabetes prevention intervention for African American (AA) children (8- to 11-years) and their parents. Power to Prevent is a lifestyle diabetes prevention intervention from the Centers for Disease Control and Prevention that is based on the Diabetes Prevention Program and tailored for AA families. To investigators knowledge, this intervention has not been evaluated in a clinical trial with AA families with children at risk for type 2 diabetes mellitus (T2DM), nor been delivered via telehealth. Employing an effectiveness-implementation hybrid study design, investigators aim to concurrently (1) conduct a single arm pilot trial to assess the early efficacy of Power to Prevent delivered via telehealth to treat overweight/obesity in AA children and their parent, while (2) evaluating an implementation strategy for the uptake of the intervention by the pediatric weight management clinic at the University of Mississippi Medical Center. The primary outcome will be stabilization or reduction in BMI z-score in children (index participant) and reduction in parent BMI (co-participant). Parents (n=20) will receive the same telehealth diabetes prevention intervention, which will be delivered by a racially concordant, trained Lifestyle Coach using small-group videoconferencing (5 parents per group). Sessions will consist of nutrition and physical activity behavior change strategies (20 min), problem solving and decision-making skills to circumvent barriers to behavioral change (20 min), and family goal setting and action planning (20 min). Child and parent measures will be assessed at baseline, 12-weeks (post-intervention), and 30-weeks (follow-up). The implementation strategy has two targets: (1) the pediatric weight management clinical and clinical care team; and (2) overweight/obese pediatric patients and their overweight/obese parents. The multifaceted implementation plan includes four discrete strategies: (1) creating a new clinical team; (2) changing the service site; (3) intervening with families; and (4) assessing organizational readiness. Preliminary findings will provide data to design a full-scale study that will include a powered pilot randomized controlled trial to test the interventions effectiveness for preventing T2DM, while evaluating a refined implementation protocol.
Read the detailed description
The Telehealth Diabetes Prevention Intervention for the Next Generation of African American Youth (TELE-GEN) pilot study will evaluate the implementation and early efficacy of a telehealth diabetes prevention intervention for African American (AA) children (8- to 11-years-old) and their parents. Power to Prevent is a lifestyle diabetes prevention intervention from the Centers for Disease Control and Prevention that is based on the Diabetes Prevention Program (DPP) and tailored specifically for AA families. To the knowledge of the study's investigators, this intervention has not yet been evaluated in a clinical trial with AA families with children at risk for T2DM, nor been delivered via telehealth. Employing an effectiveness-implementation hybrid research design, investigators aim to concurrently: (1) conduct a single arm pilot clinical trial to assess the early efficacy of Power to Prevent delivered via telehealth to treat overweight/obesity in AA children and their parent, while (2) comprehensively evaluate a multifaceted implementation strategy for the uptake of Power to Prevent delivered via telehealth by UMMC's pediatric weight management clinic. The primary outcome measure will be stabilization or reduction in BMI z-score in children (index participant) and a reduction in parent BMI (co-participant). Eligible overweight/obese children and their overweight/obese parent (N=20 families) will receive the same telehealth diabetes prevention intervention based on Power to Prevent, which will be delivered by a racially concordant Lifestyle Coach trained in the DPP. Families will meet weekly for 11-weeks (60-min sessions), and then monthly (60-min sessions) for 4 pilot behavioral reinforcement maintenance sessions (15 sessions total). Participants will meet in their respective groups (n=5 families per group) via videoconferencing using Wi-Fi-enabled tablets with cellular connectivity for the entire intervention. Sessions will consist of nutrition and physical activity behavior change strategies (20 min), problem solving and decision-making skills to circumvent barriers to behavioral change (20 min), and family goal setting and action planning (20 min). Assessment measures will be collected from the child and parent participants at baseline, 12-weeks (post-intervention), and 30-weeks (follow-up). The implementation strategy has two targets: (1) UMMC's pediatric weight management clinical setting and clinical care team; and (2) overweight/obese pediatric patients and their overweight/obese parents referred to and engaged in intensive obesity treatment for the prevention of T2DM. The multifaceted implementation plan includes four discrete strategies: (1) creating a new clinical team; (2) changing the service site; (3) intervening with families; and (4) assessing organizational readiness. Preliminary findings will provide sufficient data to design a full-scale effectiveness-implementation hybrid study that will include a powered pilot randomized controlled trial (RCT) to test the interventions effectiveness for preventing T2DM, while evaluating a refined implementation protocol. The overall purpose of the TELE-GEN pilot study directly contributes to the goal of the Jackson Heart Study Community Engagement Center by leveraging existing infrastructure and technology to engage AA families in a virtual community to prevent T2DM. The proposed aims and methods also parallel the NHLBI's strategic goal to advance transnational research.
- Conditions
- PreDiabetes, Obesity, Obesity, Childhood
- Being tested
- Power to Prevent
- Keywords
- prediabetic state, telehealth, healthy lifestyle, primary prevention, minority health
- Medical subject headings
- Prediabetic State, Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power to PreventBehavioural
Lifestyle diabetes prevention intervention based on the National Diabetes Prevention Program and tailored for African American families. The intervention will be delivered using telehealth and small group videoconferencing.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Eligible overweight/obese children and their overweight/obese parent (N=20 families) will receive the same telehealth diabetes prevention intervention based on Power to Prevent and delivered by a trained lifestyle coach. Families will meet weekly for 11-weeks (60-min sessions), and then monthly (60-min sessions) for 4 pilot behavioral reinforcement maintenance sessions (15 sessions total). Participants will meet in their respective groups (n=5 families per group) via videoconference using Wi-Fi-enabled tablets with cellular connectivity for the entire intervention. Sessions will consist of nutrition and physical activity behavior change strategies (20 min), problem solving and decision-making skills to circumvent barriers to behavioral change (20 min), and family goal setting and action planning (20 min). Assessment measures will be collected from the child and parent participants at baseline, 12-weeks (post-intervention), and 30-weeks (follow-up). Receives: Behavioral: Power to Prevent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child BMI z-score
Standard anthropometric procedures and a calibrated body weight scale (Seca 777 digital scale with stadiometer) will be used to measure participants' weight (0.1kg), stature (0.1 cm); child BMI percentile will be calculated using the statistic equations made available on the Centers for Disease Control and Prevention (CDC) website
Measured: Change from baseline child BMI z-score to 12-weeks
Child BMI z-score
Standard anthropometric procedures and a calibrated body weight scale (Seca 777 digital scale with stadiometer) will be used to measure participants' weight (0.1kg), stature (0.1 cm); child BMI percentile will be calculated using the statistic equations made available on the CDC website
Measured: Change from baseline child BMI z-score to 30-weeks
Parent BMI
Standard anthropometric procedures and a calibrated body weight scale will be used to measure participants' weight (0.1kg), stature (0.1 cm); after converting cm to m, BMI = kg/m2
Measured: Change from baseline parent BMI to 12-weeks
Parent BMI
Standard anthropometric procedures and a calibrated body weight scale will be used to measure participants' weight (0.1kg), stature (0.1 cm); after converting cm to m, BMI = kg/m2
Measured: Change from baseline parent BMI to 30-weeks
Secondary outcomes (48)
Child physical activity
Objective assessment using ActiGraph GT9X Link Accelerometers; child and parent will wear accelerometer continuously for seven day period
Measured: Change from baseline child physical activity to 12-weeks
Child physical activity
Objective assessment using ActiGraph GT9X Link Accelerometers; child and parent will wear accelerometer continuously for seven day period
Measured: Change from baseline child physical activity to 30-weeks
Parent physical activity
Objective assessment using ActiGraph GT9X Link Accelerometers; child and parent will wear accelerometer continuously for seven day period
Measured: Change from baseline parent physical activity to 12-weeks
Parent physical activity
Objective assessment using ActiGraph GT9X Link Accelerometers; child and parent will wear accelerometer continuously for seven day period
Measured: Change from baseline parent physical activity to 30-weeks
Child out-of-school sedentary time
Objective assessment using ActiGraph GT9X Link Accelerometers; child and parent will wear accelerometer continuously for seven day period
Measured: Change from baseline in child out-of-school sedentary time to 12-weeks
Child out-of-school sedentary time
Objective assessment using ActiGraph GT9X Link Accelerometers; child and parent will wear accelerometer continuously for seven day period
Measured: Change from baseline in child out-of-school sedentary time to 30-weeks
Parent sedentary time
Objective assessment using ActiGraph GT9X Link Accelerometers; child and parent will wear accelerometer continuously for seven day period
Measured: Change from baseline in parent sedentary time to 12-weeks
Parent sedentary time
Objective assessment using ActiGraph GT9X Link Accelerometers; child and parent will wear accelerometer continuously for seven day period
Measured: Change from baseline in parent sedentary time to 30-weeks
Child Hemoglobin A1c
A1CNOW+ System for reliable point-of-care HbA1c measurement; non-fasting 5 μL blood
Measured: Change from baseline child Hemoglobin A1c to 12-weeks
Child Hemoglobin A1c
A1CNOW+ System for reliable point-of-care HbA1c measurement; non-fasting 5 μL blood
Measured: Change from baseline child Hemoglobin A1c to 30-weeks
Parent Hemoglobin A1c
A1CNOW+ System for reliable point-of-care HbA1c measurement; non-fasting 5 μL blood
Measured: Change from baseline parent Hemoglobin A1c to 12-weeks
Parent Hemoglobin A1c
A1CNOW+ System for reliable point-of-care HbA1c measurement; non-fasting 5 μL blood
Measured: Change from baseline parent Hemoglobin A1c to 30-weeks
Child systolic blood pressure
Welch Allyn blood pressure unit following the American Heart Association guidelines for children.
Measured: Change from baseline child systolic blood pressure to 12-weeks
Child diastolic blood pressure
Welch Allyn blood pressure unit following the American Heart Association guidelines for children.
Measured: Change from baseline child diastolic blood pressure to 12-weeks
Child systolic blood pressure
Welch Allyn blood pressure unit following the American Heart Association guidelines for children.
Measured: Change from baseline child systolic blood pressure to 30-weeks
Child diastolic blood pressure
Welch Allyn blood pressure unit following the American Heart Association guidelines for children.
Measured: Change from baseline child diastolic blood pressure to 30-weeks
Parent systolic blood pressure
Welch Allyn blood pressure unit following the American Heart Association guidelines for adults.
Measured: Change from baseline parent systolic blood pressure to 12-weeks
Parent diastolic blood pressure
Welch Allyn blood pressure unit following the American Heart Association guidelines for adults.
Measured: Change from baseline parent diastolic blood pressure to 12-weeks
Parent systolic blood pressure
Welch Allyn blood pressure unit following the American Heart Association guidelines for adults.
Measured: Change from baseline in parent systolic blood pressure to 30-weeks
Parent diastolic blood pressure
Welch Allyn blood pressure unit following the American Heart Association guidelines for adults.
Measured: Change from baseline in parent diastolic blood pressure to 30-weeks
Child resting heart rate
Welch Allyn blood pressure unit
Measured: Change from baseline in child resting heart rate to 12-weeks
Child resting heart rate
Welch Allyn blood pressure unit
Measured: Change from baseline in child resting heart rate to 30-weeks
Parent resting heart rate
Welch Allyn blood pressure unit
Measured: Change from baseline in parent resting heart rate to 12-weeks
Parent resting heart rate
Welch Allyn blood pressure unit
Measured: Change from baseline in parent resting heart rate to 30-weeks
Parent readiness to change
Adapted from Rhee et al., a 6-item instrument to assess parents readiness and intentions to make dietary, physical activity and sedentary changes.
Measured: Change from baseline in parent readiness to change to 12-weeks
Parent readiness to change
Adapted from Rhee et al., a 6-item instrument to assess parents readiness and intentions to make dietary, physical activity and sedentary changes.
Measured: Change from baseline in parent readiness to change to 30-weeks
Parent self-efficacy
Valid and reliable (Norma et al., 2018) 14-item instrument to measure parent efficacy for influencing children's physical activity, sedentary behavior and dietary behavior using an 11-point Likert scale; 0-not confident, 10-absolutely confident.
Measured: Change from baseline in parent self-efficacy to 12-weeks
Parent self-efficacy
Valid and reliable (Norma et al., 2018) 14-item instrument to measure parent efficacy for influencing children's physical activity, sedentary behavior and dietary behavior using an 11-point Likert scale; 0-not confident, 10-absolutely confident.
Measured: Change from baseline in parent self-efficacy to 30-weeks
Child self-efficacy
A 9-item valid and reliable instrument by Lassetter et al., 2014 asking children to report their confidence on a 3-point Likert scale for eating healthy and being physically active; 1 item added to assess efficacy for watching less than 2 hours of television (TV) every day.
Measured: Change from baseline in child self-efficacy to 12-weeks
Child self-efficacy
A 9-item valid and reliable instrument by Lassetter et al., 2014 asking children to report their confidence on a 3-point Likert scale for eating healthy and being physically active; 1 item added to assess efficacy for watching less than 2 hours of TV every day.
Measured: Change from baseline in child self-efficacy to 30-weeks
Parent perceived family functioning
McMaster Family Assessment Device; a valid and reliable 60-item instrument using a 4-point Likert scale; subscales include problem solving, communication, roles, affective responsiveness, affective involvement, behavior control, general functioning
Measured: Change from baseline in parent perceived family functioning to 12-weeks
Parent perceived family functioning
McMaster Family Assessment Device; a valid and reliable 60-item instrument using a 4-point Likert scale; subscales include problem solving, communication, roles, affective responsiveness, affective involvement, behavior control, general functioning
Measured: Change from baseline in parent perceived family functioning to 30-weeks
Home physical activity and food environment
The Home Environment Survey; valid and reliable instrument (Gattshall et al., 2008) to measure the physical and social environment for food and physical activity; modified to include the physical and social environment for TV time (sedentary behavior); modified to include 79-items total; Dimensions: physical activity availability and accessibility of physical activity equipment, technology and food (i.e. fruit and vegetables); parental role modeling of physical activity, sedentary behavior, and dietary behavior.
Measured: Change from baseline in parent perceived home physical activity and food environment to 12-weeks
Home physical activity and food environment
The Home Environment Survey; valid and reliable instrument (Gattshall et al., 2008) to measure the physical and social environment for food and physical activity; modified to include the physical and social environment for TV time (sedentary behavior); modified to include 79-items total; Dimensions: physical activity availability and accessibility of physical activity equipment, technology and food (i.e. fruit and vegetables); parental role modeling of physical activity, sedentary behavior, and dietary behavior.
Measured: Change from baseline in parent perceived home physical activity and food environment to 30-weeks
Parent perceived child obesity-related behavior
Child Obesity Behavior Scale; adapted from Rhee et al., 2014; 20-items to measure food, physical activity and sedentary behavior quantity and frequency.
Measured: Change from baseline in parent perceived child health behavior to 12-weeks
Parent perceived child obesity-related behavior
Child Obesity Behavior Scale; adapted from Rhee et al., 2014; 20-items to measure food, physical activity and sedentary behavior quantity and frequency.
Measured: Change from baseline in parent perceived child health behavior to 30-weeks
Child perceived obesity-related behavior
Healthy Eating and Physical Activity Recall Questionnaire; 9-items (Lassettter et al., 2017); modified to include questions for sedentary environment; 5-items.
Measured: Change from baseline in child health behavior to 12-weeks
Child perceived obesity-related behavior
Healthy Eating and Physical Activity Recall Questionnaire; 9-items (Lassettter et al., 2017); modified to include questions for sedentary environment; 5-items.
Measured: Change from baseline in child health behavior to 30-weeks
Neighborhood Perception Survey
Valid and reliable 31-item instrument used by Mujahod et al., 2007 to assess 7 dimensions of neighborhood: aesthetic quality, walking environment, availability of healthy foods, safety, violence, social cohesion, activities with neighbors.
Measured: Change from baseline in parent neighborhood perception to 12-weeks
Neighborhood Perception Survey
Valid and reliable 31-item instrument used by Mujahod et al., 2007 to assess 7 dimensions of neighborhood: aesthetic quality, walking environment, availability of healthy foods, safety, violence, social cohesion, activities with neighbors.
Measured: Change from baseline in parent neighborhood perception to 30-weeks
Child waist circumference
A Seca 203 circumference measuring tape will be used to assess participants waist circumference.
Measured: Change from baseline in child waist circumference to 12-weeks
Child waist circumference
A Seca 203 circumference measuring tape will be used to assess participants waist circumference.
Measured: Change from baseline in child and parent waist circumference to 30-weeks
Parent waist circumference
A Seca 203 circumference measuring tape will be used to assess participants waist circumference.
Measured: Change from baseline in parent waist circumference to 12-weeks
Parent waist circumference
A Seca 203 circumference measuring tape will be used to assess participants waist circumference.
Measured: Change from baseline in parent waist circumference to 30-weeks
Parent stress
Perceived Stress Scale; 10-items (Cohen, 1994)
Measured: Change from baseline in parent stress to 12-weeks
Parent stress
Perceived Stress Scale; 10-items (Cohen, 1994)
Measured: Change from baseline in parent stress to 30-weeks
Child stress
PROMIS Pediatric Psychological and Physical Stress Scale; 19-items and 26-items (Bevans et al., 2018)
Measured: Change from baseline in parent stress to 12-weeks
Child stress
PROMIS Pediatric Psychological and Physical Stress Scale; 19-items and 26-items (Bevans et al., 2018)
Measured: Change from baseline in parent stress to 30-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Dec 2020
- Primary completion18 Dec 2021
- Study completion18 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abigail Gamble, University of Mississippi Medical Center
- Investigators
- Abigail Gamble, PhD, MS, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618458
- Sponsor's protocol ID
- AWD-000933
- Other IDs
- HHSN2682018000151
- Acronym
- TELE-GEN
- Status last verified
- Aug 2022
- First submitted
- 19 Oct 2020
- Last updated
- 8 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gamble A, Beech BM, Wade BC, Sutton VD, Lim C, Sandridge S, Welsch MA. Telehealth Diabetes Prevention Intervention for the Next Generation of African American Youth: Protocol for a Pilot Trial. JMIR Res Protoc. 2021 Mar 31;10(3):e25699. doi: 10.2196/25699.
PubMed 33787504
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Telehealth Diabetes Prevention Intervention for the Next Generation of African American Youth (TELE-GEN) Pilot Study
- ClinicalTrials.gov ID
- NCT04618458
- Acronym / sponsor ID
- TELE-GEN / AWD-000933
- Conditions
- PreDiabetes, Obesity, Obesity, Childhood
- Keywords
- prediabetic state, telehealth, healthy lifestyle, primary prevention, minority health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 18 Dec 2021 (actual)
- Study completion
- 18 Dec 2021 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Telehealth Diabetes Prevention Intervention for the Next Generation of African American Youth (TELE-GEN) pilot study will evaluate the implementation and early efficacy of a telehealth diabetes prevention intervention for African American (AA) children (8- to 11-years) and their parents. Power to Prevent is a lifestyle diabetes prevention intervention from the Centers for Disease Control and Prevention that is based on the Diabetes Prevention Program and tailored for AA families. To investigators knowledge, this intervention has not been evaluated in a clinical trial with AA families with children at risk for type 2 diabetes mellitus (T2DM), nor been delivered via telehealth. Employing an effectiveness-implementation hybrid study design, investigators aim to concurrently (1) conduct a single arm pilot trial to assess the early efficacy of Power to Prevent delivered via telehealth to treat overweight/obesity in AA children and their parent, while (2) evaluating an implementation strategy for the uptake of the intervention by the pediatric weight management clinic at the University of Mississippi Medical Center. The primary outcome will be stabilization or reduction in BMI z-score in children (index participant) and reduction in parent BMI (co-participant). Parents (n=20) will receive the same telehealth diabetes prevention intervention, which will be delivered by a racially concordant, trained Lifestyle Coach using small-group videoconferencing (5 parents per group). Sessions will consist of nutrition and physical activity behavior change strategies (20 min), problem solving and decision-making skills to circumvent barriers to behavioral change (20 min), and family goal setting and action planning (20 min). Child and parent measures will be assessed at baseline, 12-weeks (post-intervention), and 30-weeks (follow-up). The implementation strategy has two targets: (1) the pediatric weight management clinical and clinical care team; and (2) overweight/obese pediatric patients and their overweight/obese parents. The multifaceted implementation plan includes four discrete strategies: (1) creating a new clinical team; (2) changing the service site; (3) intervening with families; and (4) assessing organizational readiness. Preliminary findings will provide data to design a full-scale study that will include a powered pilot randomized controlled trial to test the interventions effectiveness for preventing T2DM, while evaluating a refined implementation protocol.
Detailed description
The Telehealth Diabetes Prevention Intervention for the Next Generation of African American Youth (TELE-GEN) pilot study will evaluate the implementation and early efficacy of a telehealth diabetes prevention intervention for African American (AA) children (8- to 11-years-old) and their parents. Power to Prevent is a lifestyle diabetes prevention intervention from the Centers for Disease Control and Prevention that is based on the Diabetes Prevention Program (DPP) and tailored specifically for AA families. To the knowledge of the study's investigators, this intervention has not yet been evaluated in a clinical trial with AA families with children at risk for T2DM, nor been delivered via telehealth. Employing an effectiveness-implementation hybrid research design, investigators aim to concurrently: (1) conduct a single arm pilot clinical trial to assess the early efficacy of Power to Prevent delivered via telehealth to treat overweight/obesity in AA children and their parent, while (2) comprehensively evaluate a multifaceted implementation strategy for the uptake of Power to Prevent delivered via telehealth by UMMC's pediatric weight management clinic. The primary outcome measure will be stabilization or reduction in BMI z-score in children (index participant) and a reduction in parent BMI (co-participant). Eligible overweight/obese children and their overweight/obese parent (N=20 families) will receive the same telehealth diabetes prevention intervention based on Power to Prevent, which will be delivered by a racially concordant Lifestyle Coach trained in the DPP. Families will meet weekly for 11-weeks (60-min sessions), and then monthly (60-min sessions) for 4 pilot behavioral reinforcement maintenance sessions (15 sessions total). Participants will meet in their respective groups (n=5 families per group) via videoconferencing using Wi-Fi-enabled tablets with cellular connectivity for the entire intervention. Sessions will consist of nutrition and physical activity behavior change strategies (20 min), problem solving and decision-making skills to circumvent barriers to behavioral change (20 min), and family goal setting and action planning (20 min). Assessment measures will be collected from the child and parent participants at baseline, 12-weeks (post-intervention), and 30-weeks (follow-up). The implementation strategy has two targets: (1) UMMC's pediatric weight management clinical setting and clinical care team; and (2) overweight/obese pediatric patients and their overweight/obese parents referred to and engaged in intensive obesity treatment for the prevention of T2DM. The multifaceted implementation plan includes four discrete strategies: (1) creating a new clinical team; (2) changing the service site; (3) intervening with families; and (4) assessing organizational readiness. Preliminary findings will provide sufficient data to design a full-scale effectiveness-implementation hybrid study that will include a powered pilot randomized controlled trial (RCT) to test the interventions effectiveness for preventing T2DM, while evaluating a refined implementation protocol. The overall purpose of the TELE-GEN pilot study directly contributes to the goal of the Jackson Heart Study Community Engagement Center by leveraging existing infrastructure and technology to engage AA families in a virtual community to prevent T2DM. The proposed aims and methods also parallel the NHLBI's strategic goal to advance transnational research.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Power to PreventEligible overweight/obese children and their overweight/obese parent (N=20 families) will receive the same telehealth diabetes prevention intervention based on Power to Prevent and delivered by a trained lifestyle coach. Families will meet weekly for 11-weeks (60-min sessions), and then monthly (60-min sessions) for 4 pilot behavioral reinforcement maintenance sessions (15 sessions total). Participants will meet in their respective groups (n=5 families per group) via videoconference using Wi-Fi-enabled tablets with cellular connectivity for the entire intervention. Sessions will consist of nutrition and physical activity behavior change strategies (20 min), problem solving and decision-making skills to circumvent barriers to behavioral change (20 min), and family goal setting and action planning (20 min). Assessment measures will be collected from the child and parent participants at baseline, 12-weeks (post-intervention), and 30-weeks (follow-up). |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- AA parents (biological, grandparent, legal guardian) and their 8- to 11-year-old child residing in the same home.
- One overweight/obese parent (BMI ≥25 kg/m2) and child (≥ 85th% age-/sex-specific BMI).
- Parent at-risk for diabetes (American Diabetes Association risk test) AND HbA1c 5.7% - 6.4%.
Key exclusion criteria (8 listed)
- child or parent has a history of T2DM or a screening HbA1c >6.4%;
- is taking glucose-lowering medications;
- is participating in a supervised weight loss program;
- is pregnant or breast feeding;
- has conditions limiting participation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Power to PreventLifestyle diabetes prevention intervention based on the National Diabetes Prevention Program and tailored for African American families. The intervention will be delivered using telehealth and small group videoconferencing. | Behavioural | Intervention Arm |
Primary outcome
Child BMI z-score
Time frame: Change from baseline child BMI z-score to 12-weeks
Standard anthropometric procedures and a calibrated body weight scale (Seca 777 digital scale with stadiometer) will be used to measure participants' weight (0.1kg), stature (0.1 cm); child BMI percentile will be calculated using the statistic equations made available on the Centers for Disease Control and Prevention (CDC) website
Child BMI z-score
Time frame: Change from baseline child BMI z-score to 30-weeks
Standard anthropometric procedures and a calibrated body weight scale (Seca 777 digital scale with stadiometer) will be used to measure participants' weight (0.1kg), stature (0.1 cm); child BMI percentile will be calculated using the statistic equations made available on the CDC website
Parent BMI
Time frame: Change from baseline parent BMI to 12-weeks
Standard anthropometric procedures and a calibrated body weight scale will be used to measure participants' weight (0.1kg), stature (0.1 cm); after converting cm to m, BMI = kg/m2
Parent BMI
Time frame: Change from baseline parent BMI to 30-weeks
Standard anthropometric procedures and a calibrated body weight scale will be used to measure participants' weight (0.1kg), stature (0.1 cm); after converting cm to m, BMI = kg/m2
48 secondary outcomes
Child physical activity
Time frame: Change from baseline child physical activity to 12-weeks
Child physical activity
Time frame: Change from baseline child physical activity to 30-weeks
Parent physical activity
Time frame: Change from baseline parent physical activity to 12-weeks
Parent physical activity
Time frame: Change from baseline parent physical activity to 30-weeks
Child out-of-school sedentary time
Time frame: Change from baseline in child out-of-school sedentary time to 12-weeks
Child out-of-school sedentary time
Time frame: Change from baseline in child out-of-school sedentary time to 30-weeks
Parent sedentary time
Time frame: Change from baseline in parent sedentary time to 12-weeks
Parent sedentary time
Time frame: Change from baseline in parent sedentary time to 30-weeks
Child Hemoglobin A1c
Time frame: Change from baseline child Hemoglobin A1c to 12-weeks
Child Hemoglobin A1c
Time frame: Change from baseline child Hemoglobin A1c to 30-weeks
Parent Hemoglobin A1c
Time frame: Change from baseline parent Hemoglobin A1c to 12-weeks
Parent Hemoglobin A1c
Time frame: Change from baseline parent Hemoglobin A1c to 30-weeks
Child systolic blood pressure
Time frame: Change from baseline child systolic blood pressure to 12-weeks
Child diastolic blood pressure
Time frame: Change from baseline child diastolic blood pressure to 12-weeks
Child systolic blood pressure
Time frame: Change from baseline child systolic blood pressure to 30-weeks
Child diastolic blood pressure
Time frame: Change from baseline child diastolic blood pressure to 30-weeks
Parent systolic blood pressure
Time frame: Change from baseline parent systolic blood pressure to 12-weeks
Parent diastolic blood pressure
Time frame: Change from baseline parent diastolic blood pressure to 12-weeks
Parent systolic blood pressure
Time frame: Change from baseline in parent systolic blood pressure to 30-weeks
Parent diastolic blood pressure
Time frame: Change from baseline in parent diastolic blood pressure to 30-weeks
Child resting heart rate
Time frame: Change from baseline in child resting heart rate to 12-weeks
Child resting heart rate
Time frame: Change from baseline in child resting heart rate to 30-weeks
Parent resting heart rate
Time frame: Change from baseline in parent resting heart rate to 12-weeks
Parent resting heart rate
Time frame: Change from baseline in parent resting heart rate to 30-weeks
Parent readiness to change
Time frame: Change from baseline in parent readiness to change to 12-weeks
Parent readiness to change
Time frame: Change from baseline in parent readiness to change to 30-weeks
Parent self-efficacy
Time frame: Change from baseline in parent self-efficacy to 12-weeks
Parent self-efficacy
Time frame: Change from baseline in parent self-efficacy to 30-weeks
Child self-efficacy
Time frame: Change from baseline in child self-efficacy to 12-weeks
Child self-efficacy
Time frame: Change from baseline in child self-efficacy to 30-weeks
Parent perceived family functioning
Time frame: Change from baseline in parent perceived family functioning to 12-weeks
Parent perceived family functioning
Time frame: Change from baseline in parent perceived family functioning to 30-weeks
Home physical activity and food environment
Time frame: Change from baseline in parent perceived home physical activity and food environment to 12-weeks
Home physical activity and food environment
Time frame: Change from baseline in parent perceived home physical activity and food environment to 30-weeks
Parent perceived child obesity-related behavior
Time frame: Change from baseline in parent perceived child health behavior to 12-weeks
Parent perceived child obesity-related behavior
Time frame: Change from baseline in parent perceived child health behavior to 30-weeks
Child perceived obesity-related behavior
Time frame: Change from baseline in child health behavior to 12-weeks
Child perceived obesity-related behavior
Time frame: Change from baseline in child health behavior to 30-weeks
Neighborhood Perception Survey
Time frame: Change from baseline in parent neighborhood perception to 12-weeks
Neighborhood Perception Survey
Time frame: Change from baseline in parent neighborhood perception to 30-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Background: PubMed 33787504Gamble A, Beech BM, Wade BC, Sutton VD, Lim C, Sandridge S, Welsch MA. Telehealth Diabetes Prevention Intervention for the Next Generation of African American Youth: Protocol for a Pilot Trial. JMIR Res Protoc. 2021 Mar 31;10(3):e25699. doi: 10.2196/25699.
- TELE-GEN ProtocolLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for PreDiabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abigail Gamble, PhD, MS principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Power to Prevent in people with PreDiabetes and Obesity, run by University of Mississippi Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child BMI z-score (time frame: Change from baseline child BMI z-score to 12-weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04618458, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022.