ObesityNCT02684214
Implementing Prevention Plus for Childhood Overweight and Obesity in Food Secure and Insecure Families
A study testing Prevention Plus + and Prevention Plus - in people with Obesity and Childhood Obesity, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
The ability of Prevention Plus to improve weight status when delivered by primary care providers is unknown, and the influence of household food security status as a moderator in the treatment of childhood obesity has never been examined. Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood Obesity
- What is being tested?
- Prevention Plus + and Prevention Plus -
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 30 Nov 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 4 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- patient at five clinics (Alcoa [Blount County], Knox County Pediatrics [Knox County], Maynardville [Union County], Seymour [Sevier County], and Talbott [Hamblen County]).
- BMI > 85th percentile
- have an adult (> 18 years) female caretaker living in the household willing to participate in the program.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthy Eating and Activity Laboratory, University of Tennessee
Knoxville, Tennessee, 37996
About this study
The ability of Prevention Plus to improve weight status when delivered by primary care providers is unknown, and the influence of household food security status as a moderator in the treatment of childhood obesity has never been examined. Thus, the investigators will conduct a randomized trial examining Prevention Plus delivered by CHS primary care providers on child zBMI in underserved children receiving their primary care at CHS who are overweight and obese, and test the moderating effect of household food security status on Prevention Plus delivered with and without caretaker goals
Read the detailed description
Intervention
PP+
Following baseline assessment, children will continue to receive standard care at CHS and the monthly newsletter. Additionally, each family will be provided with a scale; wall growth chart to measure height; a BMI wheel to calculate BMI; a BMI-for-age growth chart; a binder for intervention materials; a self-monitoring diary to record child's monthly height, weight, BMI and BMI percentile; and picture-based diaries to monitor daily energy balance behaviors. Family materials provided at each session will outline a process to measure growth and include information about how children grow, as well as cover behavioral parenting strategies to assist with changing child behavior for energy balance behaviors.
Families will meet in person with a BHC at the CHS clinic in which they receive care for 30 minutes during months 1, 3, and 5. In these sessions, child height and weight will be taken, and BMI will be plotted on the BMI-for-age growth chart. Families will receive feedback about growth and the weight status of their child. Additionally, the session materials will be reviewed and behavioral parenting strategies will be encouraged to aid with changing two dietary and two leisure-time activity (energy balance) behaviors of the child. As is traditional in a family-based approach, the caretaker will also change the same energy balance behaviors as the child, as adult caretakers can then model healthy behaviors for the child, assisting the child in learning the new weight-related behaviors.13 Thus, both the caretaker and child will be encouraged to change and self-monitor energy balance behaviors with the use of the picture-based diaries.
During months 2, 4, and 6, BHCs will complete a 20-minute phone call with the caretaker. Caretakers will be asked to measure the height and weight of their child, calculate BMI and plot it on the BMI-for-age growth chart prior to the call. During the call, the BHC will provide feedback on the changes in child growth since the previous contact. Additionally, the BHC will discuss the family's progress on achieving child and caretaker energy balance behavior goals and implementation of behavioral parenting strategies.
The child's energy balance behavioral goals will be to consume < 3 sugar-sweetened beverage (e.g., regular carbonated soft drinks, sports drinks, lemonades, ice teas, flavored milk, juice drinks < 100% juice, and punches) servings /wk, ≥1 ½ cups/day of whole vegetables and ≥ 1 cup/day of whole fruit, engage in ≥ 60 minutes/day of moderate- to vigorous-intensity physical activity, and reduce TV viewing to < 2 hours/day. The caretaker's energy balance behavioral goals will be to consume < 3 sugar-sweetened beverage servings/wk, ≥ 2 ½ cups/day of whole vegetables and ≥ 1 ½ cups/day of whole fruit, engage in ≥ 150 minutes of moderate- to vigorous-intensity physical activity per week, and reduce TV viewing to < 10 hours/wk. To increase self-efficacy, the goals will be incrementally increased, with families implementing the full program goals at month four. Additionally, children and caretakers will be asked to achieve at least three of the five goals each day (child) or week (adult caretaker).
PP-
This condition will be identical to PP+ except that caretakers will not receive any energy balance behavior goals. Additionally, the caretaker will not self-monitor energy balance behaviors. The focus will be on all other behavioral parenting strategies to assist the child with making changes in the targeted behaviors (i.e., stimulus control, positive reinforcement, and assisting child in self-monitoring energy-balance behaviors).
- Conditions
- Obesity, Childhood Obesity
- Being tested
- Prevention Plus +, Prevention Plus -
- Keywords
- food security
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevention Plus +Behavioural
Families will receive 6 monthly newsletters and meet with a BHC at the clinic for 30 minutes during months 1, 3, and 5. Child height and weight will be taken. Families will receive feedback about growth and the weight status of their child. The session materials will be reviewed and behavioral parenting strategies will be encouraged to aid with changing two dietary and two leisure-time activity (energy balance) behaviors of the child. The caretaker will also change the same energy balance behaviors as the child, as adult caretakers can then model healthy behaviors. The caretaker and child will be encouraged to change and self-monitor energy balance behaviors with the use of the picture-based diaries. During months 2, 4, and 6, BHCs will complete a 20-minute phone call with the caretaker. Caretakers will be asked to measure the height and weight of their child, calculate BMI and plot it on the BMI-for-age growth chart prior to the call. The BHC will provide feedback.
Prevention Plus -Behavioural
This condition will be identical to PP+ except that caretakers will not receive any energy balance behavior goals. Additionally, the caretaker will not self-monitor energy balance behaviors. The focus will be on all other behavioral parenting strategies to assist the child with making changes in the targeted behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Food secure families | Experimental | high and marginal household food security Receives: Behavioral: Prevention Plus +; Behavioral: Prevention Plus - |
| Food insecure families | Experimental | low and very low household food security Receives: Behavioral: Prevention Plus +; Behavioral: Prevention Plus - |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Population Denominator
CHS' Electronic Health Record will allow the number of children meeting eligibility criteria to be determined and the target population denominator identified.
Measured: 2 years
Basic demographic information and weight history
Basic demographic information (e.g., child's gender and age; parent's, gender, age, and education level) and health history will be obtained at baseline.
Measured: Baseline
Household Food Security Status assessed with the Household Food Security Module
This module consists of three stages of adult-referenced questions and two stages of child-referenced questions. The time frame that will be used to assess household food security status will be in the previous 30 days (the module is validated for a 12-month or 30 day time frame). Families will be scored as food secure (high and marginal household food security) or food insecure (low and very low household food security). This will be administered at 0 and 6 months (to assess if household food security status changed during the intervention).
Measured: Baseline
z-BMI
Measured: Change from baseline to 6-months
Child and caretaker dietary intake be assessed via 3-day food diaries
During the 3-day period(1 weekend day, 2 weekdays), if the child is under the supervision/care of another adult other than the caretaker, the caretaker will be instructed to obtain information from this other adult about what the child consumed. Families will be provided with measuring cups and spoons and two-dimensional aids to help with accuracy of recording. Caretakers will be trained on how to complete the food diaries. Diaries will be reviewed to ensure that information about food consumption is complete. Nutrition data will be analyzed using the Nutrition Data System Research Software (NDSR)
Measured: Change from baseline to 6 months
Activity assessed via Previous Day Physical Activity Recall
This is a self-report questionnaire that assesses all activity, both physical activity and sedentary behavior, in children and adolescents. Specifically, the PD-PAR collects information on screen time, allowing measurement of this targeted behavior. This questionnaire will be completed at 0 and 6 by both children and caretakers. The compendium of physical activities for youth will be used to estimate energy expenditure from the PD-PAR. Dependent variables will be minutes of physical activity and screen time, percent of time spent in sedentary behavior and moderate- to vigorous-intensity physical activity, and overall daily metabolic equivalent (MET) value.
Measured: Change from baseline to 6 months
Quality Control
Measured: 2 years
Parent Weight History
parent weight loss history will be obtained via a questionnaire
Measured: baseline
Secondary outcomes (5)
Participation Rate
Measured: 2 years
Participant vs. non-participant Characteristics
The Electronic Health Record (EHR) will allow comparisons on demographic and health characteristics between eligible children who participate vs. those who do not. CHS IT staff will extract these data from the EHR during the last 4 months of the project.
Measured: 2 years
Program Adherence assessed with a a behavioral checklist
Adherence to delivery of intervention for each session will be ascertained using a behavioral checklist
Measured: 2 years
Intervention Fidelity assessed with a behavioral checkllist
Fidelity will be ascertained by discussion of parent goals regarding energy balance behaviors in PP+ and lack of discussion regarding parent goals or changing energy balance behaviors in PP- and/or refocusing session on behavioral parenting strategies as needed.
Measured: 2 years
program sustainability assessed via interviews
Individual interviews will be conducted with at least 2 providers from each participating CHS clinic and all BHCs who delivered the PP programs to ascertain satisfaction with the approach and perceptions of sustainability of the intervention in CHS. It is anticipated that 10 CHS staff and 2 BHCs will be recruited for the 30 minute interview.
Dr. Barroso will lead this process. Interview scripts will be developed via an iterative process involving the research team.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startApr 2016
- Primary completion31 Dec 2018
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Collaborators
- Cherokee Health Systems, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Hollie Raynor, The University of Tennessee, Knoxville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684214
- Sponsor's protocol ID
- UTK IRB-15-02680-FB
- Status last verified
- Mar 2022
- First submitted
- 2 Feb 2016
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kranz S, Mitchell DC, Smiciklas-Wright H, Huang SH, Kumanyika SK, Stettler N. Consumption of recommended food groups among children from medically underserved communities. J Am Diet Assoc. 2009 Apr;109(4):702-7. doi: 10.1016/j.jada.2008.12.018.
PubMed 19328266Nackers LM, Appelhans BM. Food insecurity is linked to a food environment promoting obesity in households with children. J Nutr Educ Behav. 2013 Nov-Dec;45(6):780-4. doi: 10.1016/j.jneb.2013.08.001. Epub 2013 Sep 8.
PubMed 24021456Spear BA, Barlow SE, Ervin C, Ludwig DS, Saelens BE, Schetzina KE, Taveras EM. Recommendations for treatment of child and adolescent overweight and obesity. Pediatrics. 2007 Dec;120 Suppl 4:S254-88. doi: 10.1542/peds.2007-2329F.
PubMed 18055654Raynor HA, Osterholt KM, Hart CN, Jelalian E, Vivier P, Wing RR. Efficacy of U.S. paediatric obesity primary care guidelines: two randomized trials. Pediatr Obes. 2012 Feb;7(1):28-38. doi: 10.1111/j.2047-6310.2011.00005.x. Epub 2011 Dec 13.
PubMed 22434737Looney SM, Raynor HA. Examining the effect of three low-intensity pediatric obesity interventions: a pilot randomized controlled trial. Clin Pediatr (Phila). 2014 Dec;53(14):1367-74. doi: 10.1177/0009922814541803. Epub 2014 Jul 7.
PubMed 25006118Kitzman-Ulrich H, Wilson DK, St George SM, Lawman H, Segal M, Fairchild A. The integration of a family systems approach for understanding youth obesity, physical activity, and dietary programs. Clin Child Fam Psychol Rev. 2010 Sep;13(3):231-53. doi: 10.1007/s10567-010-0073-0.
PubMed 20689989Janicke DM, Sallinen BJ, Perri MG, Lutes LD, Huerta M, Silverstein JH, Brumback B. Comparison of parent-only vs family-based interventions for overweight children in underserved rural settings: outcomes from project STORY. Arch Pediatr Adolesc Med. 2008 Dec;162(12):1119-25. doi: 10.1001/archpedi.162.12.1119.
PubMed 19047538Wright JA, Phillips BD, Watson BL, Newby PK, Norman GJ, Adams WG. Randomized trial of a family-based, automated, conversational obesity treatment program for underserved populations. Obesity (Silver Spring). 2013 Sep;21(9):E369-78. doi: 10.1002/oby.20388. Epub 2013 Jun 11.
PubMed 23512915Dinour LM, Bergen D, Yeh MC. The food insecurity-obesity paradox: a review of the literature and the role food stamps may play. J Am Diet Assoc. 2007 Nov;107(11):1952-61. doi: 10.1016/j.jada.2007.08.006.
PubMed 17964316Metallinos-Katsaras E, Must A, Gorman K. A longitudinal study of food insecurity on obesity in preschool children. J Acad Nutr Diet. 2012 Dec;112(12):1949-58. doi: 10.1016/j.jand.2012.08.031.
PubMed 23174682Martin MA, Lippert AM. Feeding her children, but risking her health: the intersection of gender, household food insecurity and obesity. Soc Sci Med. 2012 Jun;74(11):1754-64. doi: 10.1016/j.socscimed.2011.11.013. Epub 2011 Dec 20.
PubMed 22245381Skelton JA, Buehler C, Irby MB, Grzywacz JG. Where are family theories in family-based obesity treatment?: conceptualizing the study of families in pediatric weight management. Int J Obes (Lond). 2012 Jul;36(7):891-900. doi: 10.1038/ijo.2012.56. Epub 2012 Apr 24.
PubMed 22531090Akers JD, Estabrooks PA, Davy BM. Translational research: bridging the gap between long-term weight loss maintenance research and practice. J Am Diet Assoc. 2010 Oct;110(10):1511-22, 1522.e1-3. doi: 10.1016/j.jada.2010.07.005.
PubMed 20869490Glasgow RE, Klesges LM, Dzewaltowski DA, Bull SS, Estabrooks P. The future of health behavior change research: what is needed to improve translation of research into health promotion practice? Ann Behav Med. 2004 Feb;27(1):3-12. doi: 10.1207/s15324796abm2701_2.
PubMed 14979858Livingstone MB, Robson PJ, Wallace JM. Issues in dietary intake assessment of children and adolescents. Br J Nutr. 2004 Oct;92 Suppl 2:S213-22. doi: 10.1079/bjn20041169.
PubMed 15522159
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Prevention Plus for Childhood Overweight and Obesity in Food Secure and Insecure Families
- ClinicalTrials.gov ID
- NCT02684214
- Acronym / sponsor ID
- UTK IRB-15-02680-FB
- Conditions
- Obesity, Childhood Obesity
- Keywords
- food security
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Collaborators
- Cherokee Health Systems, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Apr 2016
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 17 Feb 2016 (estimated)
- 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 ability of Prevention Plus to improve weight status when delivered by primary care providers is unknown, and the influence of household food security status as a moderator in the treatment of childhood obesity has never been examined. Thus, the investigators will conduct a randomized trial examining Prevention Plus delivered by CHS primary care providers on child zBMI in underserved children receiving their primary care at CHS who are overweight and obese, and test the moderating effect of household food security status on Prevention Plus delivered with and without caretaker goals
Detailed description
Intervention
PP+
Following baseline assessment, children will continue to receive standard care at CHS and the monthly newsletter. Additionally, each family will be provided with a scale; wall growth chart to measure height; a BMI wheel to calculate BMI; a BMI-for-age growth chart; a binder for intervention materials; a self-monitoring diary to record child's monthly height, weight, BMI and BMI percentile; and picture-based diaries to monitor daily energy balance behaviors. Family materials provided at each session will outline a process to measure growth and include information about how children grow, as well as cover behavioral parenting strategies to assist with changing child behavior for energy balance behaviors.
Families will meet in person with a BHC at the CHS clinic in which they receive care for 30 minutes during months 1, 3, and 5. In these sessions, child height and weight will be taken, and BMI will be plotted on the BMI-for-age growth chart. Families will receive feedback about growth and the weight status of their child. Additionally, the session materials will be reviewed and behavioral parenting strategies will be encouraged to aid with changing two dietary and two leisure-time activity (energy balance) behaviors of the child. As is traditional in a family-based approach, the caretaker will also change the same energy balance behaviors as the child, as adult caretakers can then model healthy behaviors for the child, assisting the child in learning the new weight-related behaviors.13 Thus, both the caretaker and child will be encouraged to change and self-monitor energy balance behaviors with the use of the picture-based diaries.
During months 2, 4, and 6, BHCs will complete a 20-minute phone call with the caretaker. Caretakers will be asked to measure the height and weight of their child, calculate BMI and plot it on the BMI-for-age growth chart prior to the call. During the call, the BHC will provide feedback on the changes in child growth since the previous contact. Additionally, the BHC will discuss the family's progress on achieving child and caretaker energy balance behavior goals and implementation of behavioral parenting strategies.
The child's energy balance behavioral goals will be to consume < 3 sugar-sweetened beverage (e.g., regular carbonated soft drinks, sports drinks, lemonades, ice teas, flavored milk, juice drinks < 100% juice, and punches) servings /wk, ≥1 ½ cups/day of whole vegetables and ≥ 1 cup/day of whole fruit, engage in ≥ 60 minutes/day of moderate- to vigorous-intensity physical activity, and reduce TV viewing to < 2 hours/day. The caretaker's energy balance behavioral goals will be to consume < 3 sugar-sweetened beverage servings/wk, ≥ 2 ½ cups/day of whole vegetables and ≥ 1 ½ cups/day of whole fruit, engage in ≥ 150 minutes of moderate- to vigorous-intensity physical activity per week, and reduce TV viewing to < 10 hours/wk. To increase self-efficacy, the goals will be incrementally increased, with families implementing the full program goals at month four. Additionally, children and caretakers will be asked to achieve at least three of the five goals each day (child) or week (adult caretaker).
PP-
This condition will be identical to PP+ except that caretakers will not receive any energy balance behavior goals. Additionally, the caretaker will not self-monitor energy balance behaviors. The focus will be on all other behavioral parenting strategies to assist the child with making changes in the targeted behaviors (i.e., stimulus control, positive reinforcement, and assisting child in self-monitoring energy-balance behaviors).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food secure families | Experimental | Behavioral: Prevention Plus +, Behavioral: Prevention Plus -high and marginal household food security |
| Food insecure families | Experimental | Behavioral: Prevention Plus +, Behavioral: Prevention Plus -low and very low household food security |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- patient at five clinics (Alcoa [Blount County], Knox County Pediatrics [Knox County], Maynardville [Union County], Seymour [Sevier County], and Talbott [Hamblen County]).
- BMI > 85th percentile
- have an adult (> 18 years) female caretaker living in the household willing to participate in the program.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Prevention Plus +Families will receive 6 monthly newsletters and meet with a BHC at the clinic for 30 minutes during months 1, 3, and 5. Child height and weight will be taken. Families will receive feedback about growth and the weight status of their child. The session materials will be reviewed and behavioral parenting strategies will be encouraged to aid with changing two dietary and two leisure-time activity (energy balance) behaviors of the child. The caretaker will also change the same energy balance behaviors as the child, as adult caretakers can then model healthy behaviors. The caretaker and child will be encouraged to change and self-monitor energy balance behaviors with the use of the picture-based diaries. During months 2, 4, and 6, BHCs will complete a 20-minute phone call with the caretaker. Caretakers will be asked to measure the height and weight of their child, calculate BMI and plot it on the BMI-for-age growth chart prior to the call. The BHC will provide feedback. | Behavioural | Food insecure families, Food secure families |
| Prevention Plus -This condition will be identical to PP+ except that caretakers will not receive any energy balance behavior goals. Additionally, the caretaker will not self-monitor energy balance behaviors. The focus will be on all other behavioral parenting strategies to assist the child with making changes in the targeted behaviors. | Behavioural | Food insecure families, Food secure families |
Primary outcome
Target Population Denominator
Time frame: 2 years
CHS' Electronic Health Record will allow the number of children meeting eligibility criteria to be determined and the target population denominator identified.
Basic demographic information and weight history
Time frame: Baseline
Basic demographic information (e.g., child's gender and age; parent's, gender, age, and education level) and health history will be obtained at baseline.
Household Food Security Status assessed with the Household Food Security Module
Time frame: Baseline
This module consists of three stages of adult-referenced questions and two stages of child-referenced questions. The time frame that will be used to assess household food security status will be in the previous 30 days (the module is validated for a 12-month or 30 day time frame). Families will be scored as food secure (high and marginal household food security) or food insecure (low and very low household food security). This will be administered at 0 and 6 months (to assess if household food security status changed during the intervention).
z-BMI
Time frame: Change from baseline to 6-months
Child and caretaker dietary intake be assessed via 3-day food diaries
Time frame: Change from baseline to 6 months
During the 3-day period(1 weekend day, 2 weekdays), if the child is under the supervision/care of another adult other than the caretaker, the caretaker will be instructed to obtain information from this other adult about what the child consumed. Families will be provided with measuring cups and spoons and two-dimensional aids to help with accuracy of recording. Caretakers will be trained on how to complete the food diaries. Diaries will be reviewed to ensure that information about food consumption is complete. Nutrition data will be analyzed using the Nutrition Data System Research Software (NDSR)
Activity assessed via Previous Day Physical Activity Recall
Time frame: Change from baseline to 6 months
This is a self-report questionnaire that assesses all activity, both physical activity and sedentary behavior, in children and adolescents. Specifically, the PD-PAR collects information on screen time, allowing measurement of this targeted behavior. This questionnaire will be completed at 0 and 6 by both children and caretakers. The compendium of physical activities for youth will be used to estimate energy expenditure from the PD-PAR. Dependent variables will be minutes of physical activity and screen time, percent of time spent in sedentary behavior and moderate- to vigorous-intensity physical activity, and overall daily metabolic equivalent (MET) value.
Quality Control
Time frame: 2 years
Parent Weight History
Time frame: baseline
parent weight loss history will be obtained via a questionnaire
5 secondary outcomes
Participation Rate
Time frame: 2 years
Participant vs. non-participant Characteristics
Time frame: 2 years
Program Adherence assessed with a a behavioral checklist
Time frame: 2 years
Intervention Fidelity assessed with a behavioral checkllist
Time frame: 2 years
program sustainability assessed via interviews
Time frame: 2 years
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 16 Mar 2022.
- Background: PubMed 19328266Kranz S, Mitchell DC, Smiciklas-Wright H, Huang SH, Kumanyika SK, Stettler N. Consumption of recommended food groups among children from medically underserved communities. J Am Diet Assoc. 2009 Apr;109(4):702-7. doi: 10.1016/j.jada.2008.12.018.
- Background: PubMed 24021456Nackers LM, Appelhans BM. Food insecurity is linked to a food environment promoting obesity in households with children. J Nutr Educ Behav. 2013 Nov-Dec;45(6):780-4. doi: 10.1016/j.jneb.2013.08.001. Epub 2013 Sep 8.
- Background: PubMed 18055654Spear BA, Barlow SE, Ervin C, Ludwig DS, Saelens BE, Schetzina KE, Taveras EM. Recommendations for treatment of child and adolescent overweight and obesity. Pediatrics. 2007 Dec;120 Suppl 4:S254-88. doi: 10.1542/peds.2007-2329F.
- Background: PubMed 22434737Raynor HA, Osterholt KM, Hart CN, Jelalian E, Vivier P, Wing RR. Efficacy of U.S. paediatric obesity primary care guidelines: two randomized trials. Pediatr Obes. 2012 Feb;7(1):28-38. doi: 10.1111/j.2047-6310.2011.00005.x. Epub 2011 Dec 13.
- Background: PubMed 25006118Looney SM, Raynor HA. Examining the effect of three low-intensity pediatric obesity interventions: a pilot randomized controlled trial. Clin Pediatr (Phila). 2014 Dec;53(14):1367-74. doi: 10.1177/0009922814541803. Epub 2014 Jul 7.
- Background: PubMed 20689989Kitzman-Ulrich H, Wilson DK, St George SM, Lawman H, Segal M, Fairchild A. The integration of a family systems approach for understanding youth obesity, physical activity, and dietary programs. Clin Child Fam Psychol Rev. 2010 Sep;13(3):231-53. doi: 10.1007/s10567-010-0073-0.
- Background: PubMed 19047538Janicke DM, Sallinen BJ, Perri MG, Lutes LD, Huerta M, Silverstein JH, Brumback B. Comparison of parent-only vs family-based interventions for overweight children in underserved rural settings: outcomes from project STORY. Arch Pediatr Adolesc Med. 2008 Dec;162(12):1119-25. doi: 10.1001/archpedi.162.12.1119.
- Background: PubMed 23512915Wright JA, Phillips BD, Watson BL, Newby PK, Norman GJ, Adams WG. Randomized trial of a family-based, automated, conversational obesity treatment program for underserved populations. Obesity (Silver Spring). 2013 Sep;21(9):E369-78. doi: 10.1002/oby.20388. Epub 2013 Jun 11.
- Background: PubMed 17964316Dinour LM, Bergen D, Yeh MC. The food insecurity-obesity paradox: a review of the literature and the role food stamps may play. J Am Diet Assoc. 2007 Nov;107(11):1952-61. doi: 10.1016/j.jada.2007.08.006.
- Background: PubMed 23174682Metallinos-Katsaras E, Must A, Gorman K. A longitudinal study of food insecurity on obesity in preschool children. J Acad Nutr Diet. 2012 Dec;112(12):1949-58. doi: 10.1016/j.jand.2012.08.031.
- Background: PubMed 22245381Martin MA, Lippert AM. Feeding her children, but risking her health: the intersection of gender, household food insecurity and obesity. Soc Sci Med. 2012 Jun;74(11):1754-64. doi: 10.1016/j.socscimed.2011.11.013. Epub 2011 Dec 20.
- Background: PubMed 22531090Skelton JA, Buehler C, Irby MB, Grzywacz JG. Where are family theories in family-based obesity treatment?: conceptualizing the study of families in pediatric weight management. Int J Obes (Lond). 2012 Jul;36(7):891-900. doi: 10.1038/ijo.2012.56. Epub 2012 Apr 24.
- Individual participant dataSharing planned: No
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Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevention Plus + and Prevention Plus - in people with Obesity and Childhood Obesity, run by The University of Tennessee, Knoxville 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 0 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 16 Mar 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?
Target Population Denominator (time frame: 2 years). The study lists 8 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 NCT02684214, which also lists 19 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 16 Mar 2022.