- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02873715
Primary Care Pediatrics Learning Activity and Nutrition With Families (PLAN)
The Effectiveness of Family-based Weight Loss Treatment Implemented in Primary Care Centers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University in St. Louis
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New York
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Buffalo, New York, United States, 14214
- University at Buffalo
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Rochester, New York, United States, 14642
- University of Rochester Medical Center
-
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Ohio
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Columbus, Ohio, United States, 43205
- Nationwide Childrens Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Usual Care (UC)
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.
|
Usual care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff.
Other Names:
|
Experimental: Family-based treatment (FBT)
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 care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff.
Other Names:
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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0 - 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Composition Measures of Participating Parent. BMI (kg/m^2) Change From Baseline to 24 Month
Time Frame: 0-24 months
|
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)
|
0-24 months
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Body Composition Measures, Siblings
Time Frame: 0-24 months
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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.
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0-24 months
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Delay of Gratification
Time Frame: 0, 12, and 24 months
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A computer task about choices will assess changes in delay of gratification for children and parents in FBT versus UC and how these changes are related to weight change.
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0, 12, and 24 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Provider attitudes toward evidence-base treatments
Time Frame: 0 month and 24 month
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A questionnaire regarding will assess providers' attitudes toward evidence-based treatments and their intentions of using it in the futureto predict their intention to incorporate co-located FBT into their practice settings.
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0 month and 24 month
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Denise Wilfley, PhD, Washington University in Saint Louis
- Principal Investigator: Ken Schechtman, PhD, Washington University in Saint Louis
- Principal Investigator: Leonard H Epstein, PhD, State University of New York at Buffalo
Publications and helpful links
General 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.
- Maddison 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.
- Epstein 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.
- Quattrin 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.
- Theim 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1131521-174563
- U01HL131552 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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