Pediatric ObesityRe-FRESHNCT02976636
Reinforced Enhanced - Families Responsibility Education Support and Health
A study testing Family-based behavioral therapy and Parenting training in people with Pediatric Obesity, run by University of California, San Diego at 1 site in United States.
Trial summary
The purpose of this application is to evaluate whether a pediatric weight control program that incorporates comprehensive parenting training with behavioral therapy can increase weight loss in children compared to traditional family-based behavioral therapy programs. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Family-based behavioral therapy and Parenting training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2017to 2 Nov 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between the ages of 7 and 12 years old;
- BMI ≥85th percentile but <100% overweight, so as to limit those children who are morbidly obese and are in need of more intense medical treatment;
- Children with mothers who are willing to attend 20 weekly group sessions and be randomized to either treatment arm;
- Have at least one parent who is overweight or obese (BMI≥25); and
- Parents who speak English at a 5th grade level.
Who cannot join
- Children with serious medical conditions that affect their weight;
- Children taking medication that affect appetite or weight;
- Children with severe developmental delay or disability that would affect participation;
- Children or parents with psychological illness that would limit treatment participation;
- Families who will move out of the area within the time frame of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
Official title: Parent Training Program to Improve Outcomes in Childhood Obesity Treatment
The purpose of this application is to evaluate whether a pediatric weight control program that incorporates comprehensive parenting training with behavioral therapy can increase weight loss in children compared to traditional family-based behavioral therapy programs. Since certain parenting styles are associated with greater weight loss during interventions and appear to enhance the impact of key behavioral strategies, adding parenting training to these interventions may increase the overall effectiveness of these programs and increase our ability to help children obtain a healthy weight. This project could result in identifying an improved method of pediatric obesity treatment that provides additional benefits to the growth and development of children via improved self-regulatory behaviors.
Read the detailed description
Authoritative parenting style has been associated with decreased obesity risk in children, increased weight loss during interventions, and can modify the delivery and impact of weight control strategies, making them more effective. At this time, gold-standard treatment for childhood obesity is family-based behavioral therapy (FBT). This treatment relies on behavioral strategies and the use of praise and a positive reinforcement system to change eating and activity behaviors, but does not target other aspects of parenting. Broadening parenting instruction to include effective limit-setting behaviors, parent-child communication, and authoritative parenting may increase parents' confidence and ability to successfully make behavior changes and modify the impact of the behavioral strategies being used. In this application, the investigators propose to test the efficacy of a 20-week weight control program that combines traditional family-based behavioral therapy with comprehensive parenting training (FBT-PT) and compare it to traditional family-based behavioral therapy (FBT). The investigators hypothesize that there will be an additive effect of parenting training such that FBT-PT will have a greater effect on child weight loss (measured by BMI z-score) than traditional FBT. In addition, the investigators will measure parenting style, parenting strategies, behavioral strategies, and child factors (like impulsive behavior and temperament) to better understand the mediators and moderators of weight loss. These measures will be obtained by standard self-report measures and videotape encounters, allowing one to more objectively measure parenting dimensions. Clinical outcomes, like drop-out and acceptability, will also be assessed from the two treatment arms. The purpose of this study is to evaluate the effect of adding a comprehensive parenting training to traditional FBT. If successful, this program will be able to increase our ability to help children successfully lose weight.
- Conditions
- Pediatric Obesity
- Being tested
- Family-based behavioral therapy, Parenting training
- Keywords
- Obesity treatment, Parenting training, Parenting style, Family-based behavioral therapy
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-based behavioral therapyBehavioural
Also called FBT, FRESH
Traditional family-based, group-based behavioral therapy for weight loss. Parent and child groups will be held separately. Intervention will consist of 20 sessions: 16 weekly sessions, and then every other week for 4 sessions.
Parenting trainingBehavioural
Also called Re-FRESH, FBT + PT
Parenting skills training for parents. Parent and child groups will be held separately and only parents will receive this training. Children will not receive any additional materials. Intervention will consist of 20 sessions: 16 weekly sessions, and then every other week for 4 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Family-based behavioral therapy (FBT) | Active comparator | Family-based behavioral therapy for pediatric weight loss Receives: Behavioral: Family-based behavioral therapy |
| Parenting training and FBT | Experimental | Family-based behavioral therapy for pediatric weight loss + parenting training to enhance outcomes Receives: Behavioral: Family-based behavioral therapy; Behavioral: Parenting training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI percentile
Change in BMI percentile at the end of treatment and follow-up period
Measured: 6 months and 18 months
Secondary outcomes (5)
Percent of families who Drop-out of study
Difference in percent of families who drop-out between groups
Measured: 6 months
Child Report of Parent Behavior Inventory
Change in parenting style from baseline to post-treatment and follow-up between groups
Measured: 6 months and 18 months
Percentage of sessions attended between groups
Difference in percentage of sessions attended between groups
Measured: 6 months
Percent of families who adhered to treatment goals
Difference in percent of families who adhered to treatment goals between groups
Measured: 6 months
Child feeding questionnaire
Change in child feed behaviors from baseline to post-treatment and follow-up between groups
Measured: 6 months and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start17 Apr 2017
- Primary completion2 Nov 2022
- Study completion2 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kay Rhee, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976636
- Sponsor's protocol ID
- 1R01DK106157
- Other IDs
- R01DK106157
- Acronym
- Re-FRESH
- Status last verified
- May 2023
- First submitted
- 21 Nov 2016
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rhee KE, Corbett T, Patel S, Eichen DM, Strong DR, Kang-Sim E, Anderson CAM, Marcus BH, Boutelle KN. Parenting Training Plus Behavioral Treatment for Children With Obesity: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e258398. doi: 10.1001/jamanetworkopen.2025.8398.
PubMed 40323600Rhee KE, Corbett T, Patel S, Eichen DM, Strong DR, Anderson C, Marcus B, Boutelle KN. A randomized controlled trial examining general parenting training and family-based behavioral treatment for childhood obesity: The ReFRESH study design. Contemp Clin Trials. 2024 Jul;142:107562. doi: 10.1016/j.cct.2024.107562. Epub 2024 May 3.
PubMed 38704118
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Training Program to Improve Outcomes in Childhood Obesity Treatment
- ClinicalTrials.gov ID
- NCT02976636
- Acronym / sponsor ID
- Re-FRESH / 1R01DK106157
- Conditions
- Pediatric Obesity
- Keywords
- Obesity treatment, Parenting training, Parenting style, Family-based behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 29 Nov 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 purpose of this application is to evaluate whether a pediatric weight control program that incorporates comprehensive parenting training with behavioral therapy can increase weight loss in children compared to traditional family-based behavioral therapy programs. Since certain parenting styles are associated with greater weight loss during interventions and appear to enhance the impact of key behavioral strategies, adding parenting training to these interventions may increase the overall effectiveness of these programs and increase our ability to help children obtain a healthy weight. This project could result in identifying an improved method of pediatric obesity treatment that provides additional benefits to the growth and development of children via improved self-regulatory behaviors.
Detailed description
Authoritative parenting style has been associated with decreased obesity risk in children, increased weight loss during interventions, and can modify the delivery and impact of weight control strategies, making them more effective. At this time, gold-standard treatment for childhood obesity is family-based behavioral therapy (FBT). This treatment relies on behavioral strategies and the use of praise and a positive reinforcement system to change eating and activity behaviors, but does not target other aspects of parenting. Broadening parenting instruction to include effective limit-setting behaviors, parent-child communication, and authoritative parenting may increase parents' confidence and ability to successfully make behavior changes and modify the impact of the behavioral strategies being used. In this application, the investigators propose to test the efficacy of a 20-week weight control program that combines traditional family-based behavioral therapy with comprehensive parenting training (FBT-PT) and compare it to traditional family-based behavioral therapy (FBT). The investigators hypothesize that there will be an additive effect of parenting training such that FBT-PT will have a greater effect on child weight loss (measured by BMI z-score) than traditional FBT. In addition, the investigators will measure parenting style, parenting strategies, behavioral strategies, and child factors (like impulsive behavior and temperament) to better understand the mediators and moderators of weight loss. These measures will be obtained by standard self-report measures and videotape encounters, allowing one to more objectively measure parenting dimensions. Clinical outcomes, like drop-out and acceptability, will also be assessed from the two treatment arms. The purpose of this study is to evaluate the effect of adding a comprehensive parenting training to traditional FBT. If successful, this program will be able to increase our ability to help children successfully lose weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family-based behavioral therapy (FBT) | Active comparator | Behavioral: Family-based behavioral therapyFamily-based behavioral therapy for pediatric weight loss |
| Parenting training and FBT | Experimental | Behavioral: Family-based behavioral therapy, Behavioral: Parenting trainingFamily-based behavioral therapy for pediatric weight loss + parenting training to enhance outcomes |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children between the ages of 7 and 12 years old;
- BMI ≥85th percentile but <100% overweight, so as to limit those children who are morbidly obese and are in need of more intense medical treatment;
- Children with mothers who are willing to attend 20 weekly group sessions and be randomized to either treatment arm;
- Have at least one parent who is overweight or obese (BMI≥25); and
- Parents who speak English at a 5th grade level.
Key exclusion criteria (5 listed)
- Children with serious medical conditions that affect their weight;
- Children taking medication that affect appetite or weight;
- Children with severe developmental delay or disability that would affect participation;
- Children or parents with psychological illness that would limit treatment participation;
- Families who will move out of the area within the time frame of the study.
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 |
|---|---|---|
| Family-based behavioral therapyAlso: FBT, FRESHTraditional family-based, group-based behavioral therapy for weight loss. Parent and child groups will be held separately. Intervention will consist of 20 sessions: 16 weekly sessions, and then every other week for 4 sessions. | Behavioural | Family-based behavioral therapy (FBT), Parenting training and FBT |
| Parenting trainingAlso: Re-FRESH, FBT + PTParenting skills training for parents. Parent and child groups will be held separately and only parents will receive this training. Children will not receive any additional materials. Intervention will consist of 20 sessions: 16 weekly sessions, and then every other week for 4 sessions. | Behavioural | Parenting training and FBT |
Primary outcome
Change in BMI percentile
Time frame: 6 months and 18 months
Change in BMI percentile at the end of treatment and follow-up period
5 secondary outcomes
Percent of families who Drop-out of study
Time frame: 6 months
Child Report of Parent Behavior Inventory
Time frame: 6 months and 18 months
Percentage of sessions attended between groups
Time frame: 6 months
Percent of families who adhered to treatment goals
Time frame: 6 months
Child feeding questionnaire
Time frame: 6 months and 18 months
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 17 May 2023.
- Derived from this study: PubMed 40323600Rhee KE, Corbett T, Patel S, Eichen DM, Strong DR, Kang-Sim E, Anderson CAM, Marcus BH, Boutelle KN. Parenting Training Plus Behavioral Treatment for Children With Obesity: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e258398. doi: 10.1001/jamanetworkopen.2025.8398.
- Derived from this study: PubMed 38704118Rhee KE, Corbett T, Patel S, Eichen DM, Strong DR, Anderson C, Marcus B, Boutelle KN. A randomized controlled trial examining general parenting training and family-based behavioral treatment for childhood obesity: The ReFRESH study design. Contemp Clin Trials. 2024 Jul;142:107562. doi: 10.1016/j.cct.2024.107562. Epub 2024 May 3.
- Individual participant dataSharing planned: No
Related trials for Pediatric Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
RecruitingPhase 3
Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS)
Obesity
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
RecruitingPhase 3
A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
Obesity, Overweight
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 Family-based behavioral therapy and Parenting training in people with Pediatric Obesity, run by University of California, San Diego 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 5 inclusion and 5 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 17 May 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?
Change in BMI percentile (time frame: 6 months and 18 months). 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 NCT02976636, which also lists 2 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 17 May 2023.