Childhood ObesityNCT04720703
A Theory Driven, Rurally Tailored, Family-Based, Telehealth Intervention for Childhood Obesity
A study testing Newsletters and Family-based Telehealth Intervention in people with Childhood Obesity, run by Indiana University at 1 site in United States.
Trial summary
This pilot trial aims to improve the lives of individuals in rural Indiana by addressing the leading cause of death, obesity. The purpose is to help children and their families develop healthy behaviors to decrease childhood obesity. Read more about this study
- Who is it for?
- Ages 5 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Newsletters and Family-based Telehealth Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2021to 30 Jun 2022
- 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 5 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 5-11 years old
- Overweight (body mass index (BMI) at or over 85th percentile, but less than 95th percentile) or Obese (BMI at or over the 95th percentile)
- living in rural Indiana
- sibling of enrolled participant - must meet all inclusion criteria with the exception of BMI
Who cannot join
- Having any of the following chronic conditions:
- developmental disabilities
- cognitive impairment
- eating disorders (e.g., anorexia nervosa, avoidant/restrictive food intake disorder, and eating disorders not elsewhere classified)
- psychiatric illnesses
- significant diagnosed medical problems (e.g., cancer) that limit physical activity, etc.
- Their only available parent parent/guardian have developmental disabilities, cognitive impairments, and psychiatric illnesses.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical and Translational Sciences Institute (CTSI)
Indianapolis, Indiana, 46202
About this study
Official title: A Theory Driven, Rurally Tailored, Family-Based, Telehealth Intervention for Childhood Obesity: A Randomized Waitlist Controlled Trial
This pilot trial aims to improve the lives of individuals in rural Indiana by addressing the leading cause of death, obesity. The purpose is to help children and their families develop healthy behaviors to decrease childhood obesity. The short-term goal of this study to develop a prototype of theory-driven, tailored, family-based, telehealth intervention that can sustainably reduce pediatric obesity rates in rural areas. The long-term goal of this study is to sustainably reduce the rates of pediatric obesity and its consequences in rural areas, via behavioral change. It is hypothesized that after participating in this intervention, children will show improvement in age-based body mass index percentile and improved behavioral indicators related to nutrition, physical activity, sleep, and sedentary behaviors. Additionally, it is hypothesized that parents will show improved attitudes and skills for managing their child's behavior and improved perceived stress and perceived quality of life. Finally, levels of attendance, participation, and technology feasibility will indicate a successful intervention.
Read the detailed description
This study will utilize a purposive (non-random) sampling strategy. Children belonging to a family headed by a parent/guardian will be identified local healthcare providers practicing in any rural Indiana counties. The sampling frame will be based on the list of pediatric patients who meet eligibility criteria who currently receive services from the rural pediatric practices. Members of the research team will not have access to any medical records. Identification of the universe of eligible participants is at the sole discretion of the healthcare provider.
This study has a set of primary and secondary objectives for children and their parents/guardians, and a separate set of hypotheses for the feasibility of intervention delivery. The short-term goal is to develop a prototype for a theory-driven, tailored, family-based, telehealth intervention that can sustainably reduce pediatric obesity rates in rural areas. The long-term goal is to sustainably reduce pediatric obesity and its consequences in rural areas, solely via behavioral change.
The primary objectives for children are to improve children's behavioral indicators in terms of nutrition, physical activity, sleep, and sedentary behaviors, measured both objectively and subjectively and sustain them over time. In the end of phase-1 (at crossover point), improvement of behavioral indicators related to nutrition, physical activity, sleep, and sedentary behaviors among children who were in the intervention group will be superior to those in the control group, however, there will be no difference after phase-2 (end of study).
The secondary objective for children is to improve children's body composition, measured with the age-sex based BMI percentile. In the end of phase 1, improvement in age-sex based BMI percentile among children who were in the intervention group will be superior to those who were in the control group; however, there will be no difference after phase 2.
The primary objectives for parents/guardians are to improve caregivers' attitudes and skills, measured as constructs in the Theory of Planned Behavior (i.e., attitudes toward behavior, subjective norms, perceived behavioral control, and response efficacy), that are necessary to change their child's behaviors. In the end of phase 1, parents/guardians who were in the intervention group will show improved attitudes and skills that evidence suggests helps to change their child's behaviors, compared to those who were in the control group.
The secondary objectives for parents/guardians is to improve perceived stress and quality of life among parents/guardians. In the end of phase 1, perceived stress and perceived quality of life among parents/guardians will be better in the intervention group than the control group; however, there will be no difference after phase 2.
The tertiary objective is to assess the feasibility of the intervention at the end of the study for the intervention group only. Intervention will have the levels of attendance and participation (i.e., interaction) and technology feasibility (i.e., internet connectivity and digital literacy) required for it to be successful.
- Conditions
- Childhood Obesity
- Being tested
- Newsletters, Family-based Telehealth Intervention
- Keywords
- childhood obesity, telehealth, family-based
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NewslettersBehavioural
Similar to prior empirical pediatric obesity interventions (Elder et al., 2009), the active attention waitlist control group will receive monthly newsletters that focus on physical activity, healthy eating, and screen time. These newsletters will be based on standard materials from the We Can program of the National Heart, Lung, and Blood Institute (NHLBI).
Family-based Telehealth InterventionBehavioural
All communications related to the intervention will occur through weekly small group video conferencing calls via Zoom and emails or text messages. The intervention will include diverse topics proven effective in prior interventions (Davis et al., 2019; McLean et al., 2003), including reading food labels, eating out, eating at social gatherings, sticker charts, praising/rewarding healthy choices, healthy foods available at home, portion sizes, healthy/easy/low-cost cooking ideas, goal setting, monitoring screen time, exercise opportunities available in neighborhood, family exercise ideas, and healthy sleep. The research team will also send relevant video/audio clips, brochures, reminders (text messages and emails) every week.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The Intervention Group will receive the Family-based Telehealth Intervention for the first three months of the study period. Once they have completed the intervention, there will be a two-week washout period. After the washout period, they will receive monthly newsletters, with similar information learned in the intervention, for three months until the end of the study period. Receives: Behavioral: Family-based Telehealth Intervention |
| Wait-list Control Group | Active comparator | The Waitlist Control Group will receive monthly newsletters, with similar information learned in the intervention, for the first three months of the study period while the Intervention Group receives the intervention. Then, there will be a two-week washout period. After the washout period, they will receive the Family-based Telehealth Intervention for 3 months until the end of the study period. Receives: Behavioral: Newsletters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Attendance
Attendance to telehealth sessions will be recorded by the interventionist and calculated as a percentage for each participant. This percentage will be calculated by dividing number of sessions attended by total number of sessions.
Measured: 26 weeks
Level of Participation
Participants are asked to complete weekly tasks (e.g. updating goal sheets) and to send researchers a picture of these updating goal sheets. Level of participation will be measured by percentage of completing these weekly tasks. This percentage will be calculated by dividing number of completed tasks by total tasks.
Measured: 26 weeks
Parent/Guardian Satisfaction
Parent/guardian satisfaction is measured using the Telehealth Satisfaction Scale, a 10-item questionnaire with a 4-point Likert scale taken by the parent/guardian and used to evaluate their satisfaction with the technology and the intervention. Total scores range from 10-40, and higher scores indicate higher satisfaction.
Measured: 26 weeks
Secondary outcomes (4)
Change in Children's Physical Activity, Sleep Behavior, and Nutrition
Physical activity and sleep behaviors will be evaluated using objective measures from Fitbit activity trackers. A blinded assessor will obtain and evaluate the child's physical activity data by measuring their number of steps per day and per hour, number of active minutes, and distance in miles. All days with more than 8 hours of recorded activity will be evaluated. The child's sleep activity will be measured by their bedtime, wake up time, total sleep time, and restless minutes. The Fitbit assessor will evaluate all days with data for total sleep and nap times. The Block Kids Food Screener for assessing nutrient and food group consumption, created by NutritionQuest, will be used to measure nutrition.
Measured: Change from baseline BMI at 12 weeks
Change in Children's Physical Activity, Sleep Behavior, and Nutrition
Physical activity and sleep behaviors will be evaluated using objective measures from Fitbit activity trackers. A blinded assessor will obtain and evaluate the child's physical activity data by measuring their number of steps per day and per hour, number of active minutes, and distance in miles. All days with more than 8 hours of recorded activity will be evaluated. The child's sleep activity will be measured by their bedtime, wake up time, total sleep time, and restless minutes. The Fitbit assessor will evaluate all days with data for total sleep and nap times. The Block Kids Food Screener for assessing nutrient and food group consumption, created by NutritionQuest, will be used to measure nutrition .
Measured: Change from 12 week BMI at 26 weeks
Change in Parents' Perceived Stress and Perceived Quality of Life
Secondary outcomes for parents/guardians are perceived stress related to childcare and perceived quality of life. The short version Parent Stress Index (PSI) is a parent/guardian self-report with 36 items. The Perceived Quality of Life Scale (PQoL) has 19 items, each with an 11-point scale, plus a global item on happiness that is utilized for comparison purposes. These will be measured at baseline, post-intervention, and after the follow-up period.
Measured: Change from baseline BMI at 12 weeks
Change in Parents' Perceived Stress and Perceived Quality of Life
Secondary outcomes for parents/guardians are perceived stress related to childcare and perceived quality of life. The short version Parent Stress Index (PSI) is a parent/guardian self-report with 36 items. The Perceived Quality of Life Scale (PQoL) has 19 items, each with an 11-point scale, plus a global item on happiness that is utilized for comparison purposes. These will be measured at baseline, post-intervention, and after the follow-up period.
Measured: Change from 12 week BMI at 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start15 Aug 2021
- Primary completion31 Mar 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wasantha P. Jayawardene, Indiana University
- Investigators
- Wasantha P Jayawardene, MD, MS, PhD, Principal investigator, Indiana University School of Public Health-BloomingtonMary Lynn Davis-Ajami, PhD, MBA, MS, Principal investigator, Indiana University School of Nursing-BloomingtonAllisandra G Kummer, Study director, Indiana University School of Public Health-BloomingtonMyat Su, Study director, Indiana University School of Public Health Bloomington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720703
- Sponsor's protocol ID
- 2002454944
- Status last verified
- May 2023
- First submitted
- 4 Jan 2021
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
Andrews KR, Silk KS, Eneli IU. Parents as health promoters: a theory of planned behavior perspective on the prevention of childhood obesity. J Health Commun. 2010 Jan;15(1):95-107. doi: 10.1080/10810730903460567.
PubMed 20390979Ayala GX, Elder JP. Qualitative methods to ensure acceptability of behavioral and social interventions to the target population. J Public Health Dent. 2011 Winter;71 Suppl 1(0 1):S69-79. doi: 10.1111/j.1752-7325.2011.00241.x.
PubMed 21656958Choi L, Liu Z, Matthews CE, Buchowski MS. Validation of accelerometer wear and nonwear time classification algorithm. Med Sci Sports Exerc. 2011 Feb;43(2):357-64. doi: 10.1249/MSS.0b013e3181ed61a3.
PubMed 20581716Davis AM, Beaver G, Dreyer Gillette M, Nelson EL, Fleming K, Swinburne Romine R, Sullivan DK, Lee R, Pettee Gabriel K, Dean K, Murray M, Faith M. iAmHealthy: Rationale, design and application of a family-based mHealth pediatric obesity intervention for rural children. Contemp Clin Trials. 2019 Mar;78:20-26. doi: 10.1016/j.cct.2019.01.001. Epub 2019 Jan 7.
PubMed 30630108Davis AM, Boles RE, James RL, Sullivan DK, Donnelly JE, Swirczynski DL, Goetz J. Health behaviors and weight status among urban and rural children. Rural Remote Health. 2008 Apr-Jun;8(2):810. Epub 2008 Apr 15.
PubMed 18426334Davis AM, James RL, Boles RE, Goetz JR, Belmont J, Malone B. The use of TeleMedicine in the treatment of paediatric obesity: feasibility and acceptability. Matern Child Nutr. 2011 Jan;7(1):71-9. doi: 10.1111/j.1740-8709.2010.00248.x.
PubMed 21108739Epstein LH, Paluch RA, Roemmich JN, Beecher MD. Family-based obesity treatment, then and now: twenty-five years of pediatric obesity treatment. Health Psychol. 2007 Jul;26(4):381-91. doi: 10.1037/0278-6133.26.4.381.
PubMed 17605557Gallagher KS, Davis AM, Malone B, Landrum Y, Black W. Treating rural pediatric obesity through telemedicine: baseline data from a randomized controlled trial. J Pediatr Psychol. 2011 Jul;36(6):687-95. doi: 10.1093/jpepsy/jsr011. Epub 2011 Mar 3.
PubMed 21372069Hunsberger M, O'Malley J, Block T, Norris JC. Relative validation of Block Kids Food Screener for dietary assessment in children and adolescents. Matern Child Nutr. 2015 Apr;11(2):260-70. doi: 10.1111/j.1740-8709.2012.00446.x. Epub 2012 Sep 24.
PubMed 23006452Marchionda DM, Slesnick N. Family therapy retention: an observation of first-session communication. J Marital Fam Ther. 2013 Jan;39(1):87-97. doi: 10.1111/j.1752-0606.2011.00279.x. Epub 2012 Feb 9.
PubMed 25073845McLean N, Griffin S, Toney K, Hardeman W. Family involvement in weight control, weight maintenance and weight-loss interventions: a systematic review of randomised trials. Int J Obes Relat Metab Disord. 2003 Sep;27(9):987-1005. doi: 10.1038/sj.ijo.0802383.
PubMed 12917703Romanzini M, Petroski EL, Ohara D, Dourado AC, Reichert FF. Calibration of ActiGraph GT3X, Actical and RT3 accelerometers in adolescents. Eur J Sport Sci. 2014;14(1):91-9. doi: 10.1080/17461391.2012.732614. Epub 2012 Oct 18.
PubMed 24533499Elder JP, Ayala GX, Slymen DJ, Arredondo EM, Campbell NR. Evaluating psychosocial and behavioral mechanisms of change in a tailored communication intervention. Health Educ Behav. 2009 Apr;36(2):366-80. doi: 10.1177/1090198107308373. Epub 2007 Dec 12.
PubMed 18077657Morgan DG, Kosteniuk J, Stewart N, O'Connell ME, Karunanayake C, Beever R. The telehealth satisfaction scale: reliability, validity, and satisfaction with telehealth in a rural memory clinic population. Telemed J E Health. 2014 Nov;20(11):997-1003. doi: 10.1089/tmj.2014.0002. Epub 2014 Oct 1.
PubMed 25272141
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Theory Driven, Rurally Tailored, Family-Based, Telehealth Intervention for Childhood Obesity: A Randomized Waitlist Controlled Trial
- ClinicalTrials.gov ID
- NCT04720703
- Acronym / sponsor ID
- 2002454944
- Conditions
- Childhood Obesity
- Keywords
- childhood obesity, telehealth, family-based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 22 Jan 2021 (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.
This pilot trial aims to improve the lives of individuals in rural Indiana by addressing the leading cause of death, obesity. The purpose is to help children and their families develop healthy behaviors to decrease childhood obesity. The short-term goal of this study to develop a prototype of theory-driven, tailored, family-based, telehealth intervention that can sustainably reduce pediatric obesity rates in rural areas. The long-term goal of this study is to sustainably reduce the rates of pediatric obesity and its consequences in rural areas, via behavioral change. It is hypothesized that after participating in this intervention, children will show improvement in age-based body mass index percentile and improved behavioral indicators related to nutrition, physical activity, sleep, and sedentary behaviors. Additionally, it is hypothesized that parents will show improved attitudes and skills for managing their child's behavior and improved perceived stress and perceived quality of life. Finally, levels of attendance, participation, and technology feasibility will indicate a successful intervention.
Detailed description
This study will utilize a purposive (non-random) sampling strategy. Children belonging to a family headed by a parent/guardian will be identified local healthcare providers practicing in any rural Indiana counties. The sampling frame will be based on the list of pediatric patients who meet eligibility criteria who currently receive services from the rural pediatric practices. Members of the research team will not have access to any medical records. Identification of the universe of eligible participants is at the sole discretion of the healthcare provider.
This study has a set of primary and secondary objectives for children and their parents/guardians, and a separate set of hypotheses for the feasibility of intervention delivery. The short-term goal is to develop a prototype for a theory-driven, tailored, family-based, telehealth intervention that can sustainably reduce pediatric obesity rates in rural areas. The long-term goal is to sustainably reduce pediatric obesity and its consequences in rural areas, solely via behavioral change.
The primary objectives for children are to improve children's behavioral indicators in terms of nutrition, physical activity, sleep, and sedentary behaviors, measured both objectively and subjectively and sustain them over time. In the end of phase-1 (at crossover point), improvement of behavioral indicators related to nutrition, physical activity, sleep, and sedentary behaviors among children who were in the intervention group will be superior to those in the control group, however, there will be no difference after phase-2 (end of study).
The secondary objective for children is to improve children's body composition, measured with the age-sex based BMI percentile. In the end of phase 1, improvement in age-sex based BMI percentile among children who were in the intervention group will be superior to those who were in the control group; however, there will be no difference after phase 2.
The primary objectives for parents/guardians are to improve caregivers' attitudes and skills, measured as constructs in the Theory of Planned Behavior (i.e., attitudes toward behavior, subjective norms, perceived behavioral control, and response efficacy), that are necessary to change their child's behaviors. In the end of phase 1, parents/guardians who were in the intervention group will show improved attitudes and skills that evidence suggests helps to change their child's behaviors, compared to those who were in the control group.
The secondary objectives for parents/guardians is to improve perceived stress and quality of life among parents/guardians. In the end of phase 1, perceived stress and perceived quality of life among parents/guardians will be better in the intervention group than the control group; however, there will be no difference after phase 2.
The tertiary objective is to assess the feasibility of the intervention at the end of the study for the intervention group only. Intervention will have the levels of attendance and participation (i.e., interaction) and technology feasibility (i.e., internet connectivity and digital literacy) required for it to be successful.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Family-based Telehealth InterventionThe Intervention Group will receive the Family-based Telehealth Intervention for the first three months of the study period. Once they have completed the intervention, there will be a two-week washout period. After the washout period, they will receive monthly newsletters, with similar information learned in the intervention, for three months until the end of the study period. |
| Wait-list Control Group | Active comparator | Behavioral: NewslettersThe Waitlist Control Group will receive monthly newsletters, with similar information learned in the intervention, for the first three months of the study period while the Intervention Group receives the intervention. Then, there will be a two-week washout period. After the washout period, they will receive the Family-based Telehealth Intervention for 3 months until the end of the study period. |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 5-11 years old
- Overweight (body mass index (BMI) at or over 85th percentile, but less than 95th percentile) or Obese (BMI at or over the 95th percentile)
- living in rural Indiana
- sibling of enrolled participant - must meet all inclusion criteria with the exception of BMI
Key exclusion criteria (7 listed)
- Having any of the following chronic conditions:
- developmental disabilities
- cognitive impairment
- eating disorders (e.g., anorexia nervosa, avoidant/restrictive food intake disorder, and eating disorders not elsewhere classified)
- psychiatric illnesses
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 |
|---|---|---|
| NewslettersSimilar to prior empirical pediatric obesity interventions (Elder et al., 2009), the active attention waitlist control group will receive monthly newsletters that focus on physical activity, healthy eating, and screen time. These newsletters will be based on standard materials from the We Can program of the National Heart, Lung, and Blood Institute (NHLBI). | Behavioural | Wait-list Control Group |
| Family-based Telehealth InterventionAll communications related to the intervention will occur through weekly small group video conferencing calls via Zoom and emails or text messages. The intervention will include diverse topics proven effective in prior interventions (Davis et al., 2019; McLean et al., 2003), including reading food labels, eating out, eating at social gatherings, sticker charts, praising/rewarding healthy choices, healthy foods available at home, portion sizes, healthy/easy/low-cost cooking ideas, goal setting, monitoring screen time, exercise opportunities available in neighborhood, family exercise ideas, and healthy sleep. The research team will also send relevant video/audio clips, brochures, reminders (text messages and emails) every week. | Behavioural | Intervention Group |
Primary outcome
Intervention Attendance
Time frame: 26 weeks
Attendance to telehealth sessions will be recorded by the interventionist and calculated as a percentage for each participant. This percentage will be calculated by dividing number of sessions attended by total number of sessions.
Level of Participation
Time frame: 26 weeks
Participants are asked to complete weekly tasks (e.g. updating goal sheets) and to send researchers a picture of these updating goal sheets. Level of participation will be measured by percentage of completing these weekly tasks. This percentage will be calculated by dividing number of completed tasks by total tasks.
Parent/Guardian Satisfaction
Time frame: 26 weeks
Parent/guardian satisfaction is measured using the Telehealth Satisfaction Scale, a 10-item questionnaire with a 4-point Likert scale taken by the parent/guardian and used to evaluate their satisfaction with the technology and the intervention. Total scores range from 10-40, and higher scores indicate higher satisfaction.
4 secondary outcomes
Change in Children's Physical Activity, Sleep Behavior, and Nutrition
Time frame: Change from baseline BMI at 12 weeks
Change in Children's Physical Activity, Sleep Behavior, and Nutrition
Time frame: Change from 12 week BMI at 26 weeks
Change in Parents' Perceived Stress and Perceived Quality of Life
Time frame: Change from baseline BMI at 12 weeks
Change in Parents' Perceived Stress and Perceived Quality of Life
Time frame: Change from 12 week BMI at 26 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 2 Jun 2023.
- Background: PubMed 20390979Andrews KR, Silk KS, Eneli IU. Parents as health promoters: a theory of planned behavior perspective on the prevention of childhood obesity. J Health Commun. 2010 Jan;15(1):95-107. doi: 10.1080/10810730903460567.
- Background: PubMed 21656958Ayala GX, Elder JP. Qualitative methods to ensure acceptability of behavioral and social interventions to the target population. J Public Health Dent. 2011 Winter;71 Suppl 1(0 1):S69-79. doi: 10.1111/j.1752-7325.2011.00241.x.
- Background: PubMed 20581716Choi L, Liu Z, Matthews CE, Buchowski MS. Validation of accelerometer wear and nonwear time classification algorithm. Med Sci Sports Exerc. 2011 Feb;43(2):357-64. doi: 10.1249/MSS.0b013e3181ed61a3.
- Background: PubMed 30630108Davis AM, Beaver G, Dreyer Gillette M, Nelson EL, Fleming K, Swinburne Romine R, Sullivan DK, Lee R, Pettee Gabriel K, Dean K, Murray M, Faith M. iAmHealthy: Rationale, design and application of a family-based mHealth pediatric obesity intervention for rural children. Contemp Clin Trials. 2019 Mar;78:20-26. doi: 10.1016/j.cct.2019.01.001. Epub 2019 Jan 7.
- Background: PubMed 18426334Davis AM, Boles RE, James RL, Sullivan DK, Donnelly JE, Swirczynski DL, Goetz J. Health behaviors and weight status among urban and rural children. Rural Remote Health. 2008 Apr-Jun;8(2):810. Epub 2008 Apr 15.
- Background: PubMed 21108739Davis AM, James RL, Boles RE, Goetz JR, Belmont J, Malone B. The use of TeleMedicine in the treatment of paediatric obesity: feasibility and acceptability. Matern Child Nutr. 2011 Jan;7(1):71-9. doi: 10.1111/j.1740-8709.2010.00248.x.
- Background: PubMed 17605557Epstein LH, Paluch RA, Roemmich JN, Beecher MD. Family-based obesity treatment, then and now: twenty-five years of pediatric obesity treatment. Health Psychol. 2007 Jul;26(4):381-91. doi: 10.1037/0278-6133.26.4.381.
- Background: PubMed 21372069Gallagher KS, Davis AM, Malone B, Landrum Y, Black W. Treating rural pediatric obesity through telemedicine: baseline data from a randomized controlled trial. J Pediatr Psychol. 2011 Jul;36(6):687-95. doi: 10.1093/jpepsy/jsr011. Epub 2011 Mar 3.
- Background: PubMed 23006452Hunsberger M, O'Malley J, Block T, Norris JC. Relative validation of Block Kids Food Screener for dietary assessment in children and adolescents. Matern Child Nutr. 2015 Apr;11(2):260-70. doi: 10.1111/j.1740-8709.2012.00446.x. Epub 2012 Sep 24.
- Background: PubMed 25073845Marchionda DM, Slesnick N. Family therapy retention: an observation of first-session communication. J Marital Fam Ther. 2013 Jan;39(1):87-97. doi: 10.1111/j.1752-0606.2011.00279.x. Epub 2012 Feb 9.
- Background: PubMed 12917703McLean N, Griffin S, Toney K, Hardeman W. Family involvement in weight control, weight maintenance and weight-loss interventions: a systematic review of randomised trials. Int J Obes Relat Metab Disord. 2003 Sep;27(9):987-1005. doi: 10.1038/sj.ijo.0802383.
- Background: PubMed 24533499Romanzini M, Petroski EL, Ohara D, Dourado AC, Reichert FF. Calibration of ActiGraph GT3X, Actical and RT3 accelerometers in adolescents. Eur J Sport Sci. 2014;14(1):91-9. doi: 10.1080/17461391.2012.732614. Epub 2012 Oct 18.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Wasantha P Jayawardene, MD, MS, PhD principal investigator
Indiana University School of Public Health-Bloomington
Mary Lynn Davis-Ajami, PhD, MBA, MS principal investigator
Indiana University School of Nursing-Bloomington
Allisandra G Kummer study director
Indiana University School of Public Health-Bloomington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Newsletters and Family-based Telehealth Intervention in people with Childhood Obesity, run by Indiana University 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 4 inclusion and 7 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 2 Jun 2023. 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?
Intervention Attendance (time frame: 26 weeks). The study lists 3 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 NCT04720703, which also lists 14 linked publications.
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 2 Jun 2023.