Pediatric ObesityPLANNCT02873715
Primary Care Pediatrics Learning Activity and Nutrition With Families
A study testing Family-based treatment in people with Pediatric Obesity, run by State University of New York at Buffalo at 4 sites in United States.
Trial summary
This study is designed to translate an evidence-based family-based weight loss treatment for childhood obesity (FBT) into primary care settings using co-located interventionists to serve as a model for care delivered within a patient-centered medical home. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Family-based treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,010 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Nov 2017to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The participating child will be between the ages of 6 and 12 and have a BMI above the 85th percentile for age and sex. The participating child will have at least one parent who has overweight or obesity (BMI>25) and who must agree to attend all parent/child treatment meetings as the participating parent. For families in which one parent has overweight/obesity, this parent will be required to be the participating parent in order for the family to be eligible for the study; if two parents have overweight/obesity, the family will choose one parent to enroll in the study. Similarly, if two children in the family have overweight/obesity, it will be encouraged that the older sibling be the primary participant, as it is more likely the younger sibling will model the older sibling. Though only the child who has overweight/obesity and the participating parent will be required to attend treatment sessions, all family members living in the household, including other adults and siblings, will be encouraged to participate indirectly by supporting changes in the family's lifestyle. Because a secondary aim of the study involves the tracking of treatment effects through the household to non-targeted siblings, heights and weights of at least one sibling with overweight/obesity (BMI>85th percentile for age and sex)in the family will be collected, if applicable. Only siblings ages 2- 18 would qualify. All participants must be able to speak and comprehend English at a first-grade level.
Who cannot join
- The participating parent or child will not have had a concussion in the past three months; will not have any significant developmental delays or intellectual disabilities; will not be receiving treatment for a Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-5) disorder that interferes with treatment delivered as part of the intervention; will not have a physical disability or diagnosis that prevents performance of physical activity at a level equivalent to a brisk walk or that places severe restriction on diet; will not be on a medication regimen that affects weight; will not have a medical condition that alters nutritional status, intestinal absorption, or affects weight; will not have undergone weight loss surgery; and will not be participating in an alternate weight control program. Families in which either the participating child or parent is actively involved in other weight-loss treatment, is using weight-affecting medications, or has an impairing psychiatric or medical condition that would hinder participation in the study will be excluded as identified by the screening assessments. Families that are planning to move or in which the participating parent is pregnant or is planning on becoming pregnant during the 2 year study period will also be excluded.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University at Buffalo
Buffalo, New York, 14214
Nationwide Childrens Hospital
Columbus, Ohio, 43205
University of Rochester Medical Center
Rochester, New York, 14642
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: The Effectiveness of Family-based Weight Loss Treatment Implemented in Primary Care Centers
This study is designed to translate an evidence-based family-based weight loss treatment for childhood obesity (FBT) into primary care settings using co-located interventionists to serve as a model for care delivered within a patient-centered medical home. FBT will be compared to usual care (UC), and the families will be followed for a 2 year period to assess between group differences in the targeted child and parent outcomes, weight changes in non-targeted siblings who are overweight/obese, parent and child changes in delay of gratification, and how these changes relate to weight loss, and the assessment of how provider attitudes predict their intention to use FBT in the future. The results of this study will inform future dissemination and implementation of FBT into primary care settings.
Read the detailed description
Family-based treatment (FBT) is a behavioral weight control intervention that targets children who have overweight/obesity and their parents, and has the capacity to improve the weight status of non-targeted family members such as siblings. FBT has significant positive effects on body weight in children for up to 10-years of follow-up, and a robust relationship is observed between child and parent outcomes. FBT's concurrent care of two generations of obesity in the family is more efficacious and cost-effective than if family members are treated by their separate health care providers. Despite its recognized efficacy, FBT is mainly available in specialty clinics and many children fail to receive this guideline-based level of treatment, as recommended by the U.S. Preventive Services Task Force. Primary care offers an optimal setting for delivery of FBT by capitalizing on the established relationship between primary care providers and families. Using interventionists co-located within the primary care setting overcomes barriers posed by fragmentation of care, and lack of provider time and training. One of the challenges to integrating childhood obesity treatment into primary care is optimizing limited health care resources. In behavioral weight loss programs, some individuals learn diet, physical activity, and behavior change information quickly, while others learn more slowly. Individuals also differ in their ability to implement treatment recommendations due to individual differences, such as problems with delaying gratification. FBT accommodates these individual differences by using a personalized system of instruction, or a mastery model, in which the content and dose of treatment is calibrated to the needs of the family, ensuring that treatment effort is consistent with need. This multi-site, clinical trial aims to evaluate over a two year period the effectiveness of FBT delivered by a trained interventionist co-located within primary care plus usual care delivered by the primary care provider (FBT) compared to usual care (UC). Participants will be a representative sample of 528 families with a 6-12 year-old child and a parent who have both overweight/obesity. Weight changes in approximately 228 siblings who have overweight/obesity and between 2-18 years of age will also be studied. This study will test between group differences in child (Primary Specific Aim 1A) and parent (Secondary Specific Aim 1) weight change, as well as weight change in siblings who have overweight/obesity (Secondary Aim 2), changes in parent and child delay of gratification, and how changes in delay of gratification are related to parent and child weight changes (Secondary Aim 3), participant level predictors of treatment success (Secondary Aim 4), and how provider attitudes toward evidence-based treatment and perceptions of FBT may relate to their intention to use colocated FBT in their practices in the future (Exploratory Aim 1). Establishing that FBT can be effectively implemented within real world settings is crucial to creating a system by which children and their families who suffer from obesity can be treated in a centralized primary care setting.
- Conditions
- Pediatric Obesity
- Being tested
- Family-based treatment, Usual Care
- Keywords
- Childhood weight control
- 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 treatmentBehavioural
Also called FBT
Family based treatment as the invention to randomized participants. Family Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two year study
Usual CareBehavioural
Also called UC
Usual care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care (UC) | Active comparator | Usual Care will consist of the care typically delivered by the family's primary care provider for children with overweight or obesity. The implementations of UC may vary between providers but typically includes and assessment of the child's weight, help remove barriers to weight loss and introductions of goals for better weight management. Receives: Behavioral: Usual Care |
| Family-based treatment (FBT) | Experimental | Family- Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two year study Receives: Behavioral: Family-based treatment; Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition Measures of Targeted Child. Percent Change Over the Median BMI
Height and weight will be taken to calculate changes in over weight status for children in FBT versus UC. Change in percent over median BMI from baseline to 24-month. Percent over the age- and sex-specific 50th BMI percentile for kids, percent over the sex-specific 50th BMI percentile for 20-year-olds for parents. Parents are not included in this measurement. This measurement is to describe child body composition and not used for parents. Results are pooled across 10 multiple imputations and reported as mean (standard error)
Measured: 0 - 24 months
Secondary outcomes (3)
Body Composition Measures of Participating Parent. BMI (kg/m^2) Change From Baseline to 24 Month
Height and weight will be taken to calculate changes in over weight status for parents in FBT versus UC. Results are pooled across 10 multiple imputations and reported as mean (standard error)
Measured: 0-24 months
Body Composition Measures, Siblings
Height and weight will be taken for non-targeted siblings to determine if weight loss effects of FBT extend beyond the participating parent and child.
Measured: 0-24 months
Delay Discounting
Delay discounting will be measured using an adjusting amount discounting task with a delayed reward of $100. K-values will be calculated and log-versions will be used due to skewness of k-values. More negative k-values indicate more delayed choices, which is considered better decision making
Measured: 0, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start20 Nov 2017
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)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 State University of New York at BuffaloThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,010 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Leonard Epstein, State University of New York at Buffalo
- Investigators
- Leonard H Epstein, PhD, Principal investigator, State University of New York at BuffaloDenise Wilfley, PhD, Principal investigator, Washington University in Saint LouisKen Schechtman, PhD, Principal investigator, Washington University in Saint Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873715
- Sponsor's protocol ID
- 1131521-174563
- Other IDs
- U01HL131552
- Acronym
- PLAN
- Status last verified
- Jun 2024
- First submitted
- 17 Aug 2016
- Last updated
- 26 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kolko RP, Kass AE, Hayes JF, Levine MD, Garbutt JM, Proctor EK, Wilfley DE. Provider Training to Screen and Initiate Evidence-Based Pediatric Obesity Treatment in Routine Practice Settings: A Randomized Pilot Trial. J Pediatr Health Care. 2017 Jan-Feb;31(1):16-28. doi: 10.1016/j.pedhc.2016.01.001. Epub 2016 Feb 9.
PubMed 26873293Maddison R, Marsh S, Foley L, Epstein LH, Olds T, Dewes O, Heke I, Carter K, Jiang Y, Mhurchu CN. Screen-Time Weight-loss Intervention Targeting Children at Home (SWITCH): a randomized controlled trial. Int J Behav Nutr Phys Act. 2014 Sep 10;11:111. doi: 10.1186/s12966-014-0111-2.
PubMed 25204320Epstein LH, Paluch RA, Wrotniak BH, Daniel TO, Kilanowski C, Wilfley D, Finkelstein E. Cost-effectiveness of family-based group treatment for child and parental obesity. Child Obes. 2014 Apr;10(2):114-21. doi: 10.1089/chi.2013.0123. Epub 2014 Mar 21.
PubMed 24655212Quattrin T, Roemmich JN, Paluch R, Yu J, Epstein LH, Ecker MA. Efficacy of family-based weight control program for preschool children in primary care. Pediatrics. 2012 Oct;130(4):660-6. doi: 10.1542/peds.2012-0701. Epub 2012 Sep 17.
PubMed 22987879Theim KR, Sinton MM, Stein RI, Saelens BE, Thekkedam SC, Welch RR, Epstein LH, Wilfley DE. Preadolescents' and parents' dietary coping efficacy during behavioral family-based weight control treatment. J Youth Adolesc. 2012 Jan;41(1):86-97. doi: 10.1007/s10964-011-9728-5. Epub 2011 Nov 12.
PubMed 22081241Button AM, Paluch RA, Schechtman KB, Wilfley DE, Geller N, Quattrin T, Cook SR, Eneli IU, Epstein LH. Parents, but not their children, demonstrate greater delay discounting with resource scarcity. BMC Public Health. 2023 Oct 12;23(1):1983. doi: 10.1186/s12889-023-16832-z.
PubMed 37828503Epstein LH, Rizwan A, Paluch RA, Temple JL. Delay Discounting and the Income-Food Insecurity-Obesity Paradox in Mothers. J Obes. 2023 Sep 19;2023:8898498. doi: 10.1155/2023/8898498. eCollection 2023.
PubMed 37766882Epstein LH, Wilfley DE, Kilanowski C, Quattrin T, Cook SR, Eneli IU, Geller N, Lew D, Wallendorf M, Dore P, Paluch RA, Schechtman KB. Family-Based Behavioral Treatment for Childhood Obesity Implemented in Pediatric Primary Care: A Randomized Clinical Trial. JAMA. 2023 Jun 13;329(22):1947-1956. doi: 10.1001/jama.2023.8061.
PubMed 37314275
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Family-based Weight Loss Treatment Implemented in Primary Care Centers
- ClinicalTrials.gov ID
- NCT02873715
- Acronym / sponsor ID
- PLAN / 1131521-174563
- Conditions
- Pediatric Obesity
- Keywords
- Childhood weight control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,010 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Posted 14 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to translate an evidence-based family-based weight loss treatment for childhood obesity (FBT) into primary care settings using co-located interventionists to serve as a model for care delivered within a patient-centered medical home. FBT will be compared to usual care (UC), and the families will be followed for a 2 year period to assess between group differences in the targeted child and parent outcomes, weight changes in non-targeted siblings who are overweight/obese, parent and child changes in delay of gratification, and how these changes relate to weight loss, and the assessment of how provider attitudes predict their intention to use FBT in the future. The results of this study will inform future dissemination and implementation of FBT into primary care settings.
Detailed description
Family-based treatment (FBT) is a behavioral weight control intervention that targets children who have overweight/obesity and their parents, and has the capacity to improve the weight status of non-targeted family members such as siblings. FBT has significant positive effects on body weight in children for up to 10-years of follow-up, and a robust relationship is observed between child and parent outcomes. FBT's concurrent care of two generations of obesity in the family is more efficacious and cost-effective than if family members are treated by their separate health care providers. Despite its recognized efficacy, FBT is mainly available in specialty clinics and many children fail to receive this guideline-based level of treatment, as recommended by the U.S. Preventive Services Task Force. Primary care offers an optimal setting for delivery of FBT by capitalizing on the established relationship between primary care providers and families. Using interventionists co-located within the primary care setting overcomes barriers posed by fragmentation of care, and lack of provider time and training. One of the challenges to integrating childhood obesity treatment into primary care is optimizing limited health care resources. In behavioral weight loss programs, some individuals learn diet, physical activity, and behavior change information quickly, while others learn more slowly. Individuals also differ in their ability to implement treatment recommendations due to individual differences, such as problems with delaying gratification. FBT accommodates these individual differences by using a personalized system of instruction, or a mastery model, in which the content and dose of treatment is calibrated to the needs of the family, ensuring that treatment effort is consistent with need. This multi-site, clinical trial aims to evaluate over a two year period the effectiveness of FBT delivered by a trained interventionist co-located within primary care plus usual care delivered by the primary care provider (FBT) compared to usual care (UC). Participants will be a representative sample of 528 families with a 6-12 year-old child and a parent who have both overweight/obesity. Weight changes in approximately 228 siblings who have overweight/obesity and between 2-18 years of age will also be studied. This study will test between group differences in child (Primary Specific Aim 1A) and parent (Secondary Specific Aim 1) weight change, as well as weight change in siblings who have overweight/obesity (Secondary Aim 2), changes in parent and child delay of gratification, and how changes in delay of gratification are related to parent and child weight changes (Secondary Aim 3), participant level predictors of treatment success (Secondary Aim 4), and how provider attitudes toward evidence-based treatment and perceptions of FBT may relate to their intention to use colocated FBT in their practices in the future (Exploratory Aim 1). Establishing that FBT can be effectively implemented within real world settings is crucial to creating a system by which children and their families who suffer from obesity can be treated in a centralized primary care setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care (UC) | Active comparator | Behavioral: Usual CareUsual Care will consist of the care typically delivered by the family's primary care provider for children with overweight or obesity. The implementations of UC may vary between providers but typically includes and assessment of the child's weight, help remove barriers to weight loss and introductions of goals for better weight management. |
| Family-based treatment (FBT) | Experimental | Behavioral: Family-based treatment, Behavioral: Usual CareFamily- Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two year study |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The participating child will be between the ages of 6 and 12 and have a BMI above the 85th percentile for age and sex. The participating child will have at least one parent who has overweight or obesity (BMI>25) and who must agree to attend all parent/child treatment meetings as the participating parent. For families in which one parent has overweight/obesity, this parent will be required to be the participating parent in order for the family to be eligible for the study; if two parents have overweight/obesity, the family will choose one parent to enroll in the study. Similarly, if two children in the family have overweight/obesity, it will be encouraged that the older sibling be the primary participant, as it is more likely the younger sibling will model the older sibling. Though only the child who has overweight/obesity and the participating parent will be required to attend treatment sessions, all family members living in the household, including other adults and siblings, will be encouraged to participate indirectly by supporting changes in the family's lifestyle. Because a secondary aim of the study involves the tracking of treatment effects through the household to non-targeted siblings, heights and weights of at least one sibling with overweight/obesity (BMI>85th percentile for age and sex)in the family will be collected, if applicable. Only siblings ages 2- 18 would qualify. All participants must be able to speak and comprehend English at a first-grade level.
Key exclusion criteria (1 listed)
- The participating parent or child will not have had a concussion in the past three months; will not have any significant developmental delays or intellectual disabilities; will not be receiving treatment for a Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-5) disorder that interferes with treatment delivered as part of the intervention; will not have a physical disability or diagnosis that prevents performance of physical activity at a level equivalent to a brisk walk or that places severe restriction on diet; will not be on a medication regimen that affects weight; will not have a medical condition that alters nutritional status, intestinal absorption, or affects weight; will not have undergone weight loss surgery; and will not be participating in an alternate weight control program. Families in which either the participating child or parent is actively involved in other weight-loss treatment, is using weight-affecting medications, or has an impairing psychiatric or medical condition that would hinder participation in the study will be excluded as identified by the screening assessments. Families that are planning to move or in which the participating parent is pregnant or is planning on becoming pregnant during the 2 year study period will also be excluded.
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 treatmentAlso: FBTFamily based treatment as the invention to randomized participants. Family Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two year study | Behavioural | Family-based treatment (FBT) |
| Usual CareAlso: UCUsual care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff. | Behavioural | Family-based treatment (FBT), Usual Care (UC) |
Primary outcome
Body Composition Measures of Targeted Child. Percent Change Over the Median BMI
Time frame: 0 - 24 months
Height and weight will be taken to calculate changes in over weight status for children in FBT versus UC. Change in percent over median BMI from baseline to 24-month. Percent over the age- and sex-specific 50th BMI percentile for kids, percent over the sex-specific 50th BMI percentile for 20-year-olds for parents. Parents are not included in this measurement. This measurement is to describe child body composition and not used for parents. Results are pooled across 10 multiple imputations and reported as mean (standard error)
3 secondary outcomes
Body Composition Measures of Participating Parent. BMI (kg/m^2) Change From Baseline to 24 Month
Time frame: 0-24 months
Body Composition Measures, Siblings
Time frame: 0-24 months
Delay Discounting
Time frame: 0, and 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26873293Kolko RP, Kass AE, Hayes JF, Levine MD, Garbutt JM, Proctor EK, Wilfley DE. Provider Training to Screen and Initiate Evidence-Based Pediatric Obesity Treatment in Routine Practice Settings: A Randomized Pilot Trial. J Pediatr Health Care. 2017 Jan-Feb;31(1):16-28. doi: 10.1016/j.pedhc.2016.01.001. Epub 2016 Feb 9.
- Background: PubMed 25204320Maddison R, Marsh S, Foley L, Epstein LH, Olds T, Dewes O, Heke I, Carter K, Jiang Y, Mhurchu CN. Screen-Time Weight-loss Intervention Targeting Children at Home (SWITCH): a randomized controlled trial. Int J Behav Nutr Phys Act. 2014 Sep 10;11:111. doi: 10.1186/s12966-014-0111-2.
- Background: PubMed 24655212Epstein LH, Paluch RA, Wrotniak BH, Daniel TO, Kilanowski C, Wilfley D, Finkelstein E. Cost-effectiveness of family-based group treatment for child and parental obesity. Child Obes. 2014 Apr;10(2):114-21. doi: 10.1089/chi.2013.0123. Epub 2014 Mar 21.
- Background: PubMed 22987879Quattrin T, Roemmich JN, Paluch R, Yu J, Epstein LH, Ecker MA. Efficacy of family-based weight control program for preschool children in primary care. Pediatrics. 2012 Oct;130(4):660-6. doi: 10.1542/peds.2012-0701. Epub 2012 Sep 17.
- Background: PubMed 22081241Theim KR, Sinton MM, Stein RI, Saelens BE, Thekkedam SC, Welch RR, Epstein LH, Wilfley DE. Preadolescents' and parents' dietary coping efficacy during behavioral family-based weight control treatment. J Youth Adolesc. 2012 Jan;41(1):86-97. doi: 10.1007/s10964-011-9728-5. Epub 2011 Nov 12.
- Derived from this study: PubMed 37828503Button AM, Paluch RA, Schechtman KB, Wilfley DE, Geller N, Quattrin T, Cook SR, Eneli IU, Epstein LH. Parents, but not their children, demonstrate greater delay discounting with resource scarcity. BMC Public Health. 2023 Oct 12;23(1):1983. doi: 10.1186/s12889-023-16832-z.
- Derived from this study: PubMed 37766882Epstein LH, Rizwan A, Paluch RA, Temple JL. Delay Discounting and the Income-Food Insecurity-Obesity Paradox in Mothers. J Obes. 2023 Sep 19;2023:8898498. doi: 10.1155/2023/8898498. eCollection 2023.
- Derived from this study: PubMed 37314275Epstein LH, Wilfley DE, Kilanowski C, Quattrin T, Cook SR, Eneli IU, Geller N, Lew D, Wallendorf M, Dore P, Paluch RA, Schechtman KB. Family-Based Behavioral Treatment for Childhood Obesity Implemented in Pediatric Primary Care: A Randomized Clinical Trial. JAMA. 2023 Jun 13;329(22):1947-1956. doi: 10.1001/jama.2023.8061.
- Ten-year outcomes of behavioral family-based treatment for childhood obesity. Epstein, Leonard H.; Valoski, Alice; Wing, Rena R.; McCurley, James Health Psychology, Vol 13(5), Sep 1994, 373-383. http://dx.doi.org/10.1037/0278-Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Leonard H Epstein, PhD principal investigator
State University of New York at Buffalo
Denise Wilfley, PhD principal investigator
Washington University in Saint Louis
Ken Schechtman, PhD principal investigator
Washington University in Saint Louis
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-based treatment in people with Pediatric Obesity, run by State University of New York at Buffalo at 4 sites 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 1 inclusion and 1 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 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Body Composition Measures of Targeted Child. Percent Change Over the Median BMI (time frame: 0 - 24 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 NCT02873715, which also lists 8 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 26 Jul 2024.