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FRESH-DOSE: Families Responsibility Education Support Health—Dual Options for Sustained Effectiveness

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ClinicalTrials.gov Identifier: NCT03096132
Recruitment Status : Recruiting
First Posted : March 30, 2017
Last Update Posted : June 27, 2019
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Kerri Boutelle, University of California, San Diego

Brief Summary:
The objective of the study is to evaluate whether a less intensive intervention, Guided Self-Help Family Based Treatment (gshFBT), is non-inferior to the more intensive Family Based Treatment (FBT) for childhood obesity on child weight loss over 18-months. Cost-effectiveness of both treatments will also be compared.

Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: Family Based Behavioral Treatment Behavioral: Guided Self-Help Fam. Based Bx Treatment Not Applicable

Detailed Description:
The primary aim of this project is to determine whether gshFBT is non-inferior to FBT for childhood obesity on child weight loss. Four assessments will be conducted; baseline (month 0), month 6 (post-treatment), and at month 12 and month 18. Assessments will include the following for child and parent: anthropometry, physical activity, nutrition, and cost-effectiveness. Cost-effectiveness will be calculated from a societal perspective and a third party payor perspective. This program of research has the potential to advance the standard of practice for children who are overweight or obese by providing a less intensive but more cost-effective intervention.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Treatment Dose on Childhood Obesity
Actual Study Start Date : April 18, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
Active Comparator: Family Based Behavioral Treatment
The program includes information about diet and physical activity education, in addition to parent management skills and behavior therapy strategies in a weekly group setting.
Behavioral: Family Based Behavioral Treatment
Treatment includes 20 90 minute visits over 6 months which include 60 min parent and child separate groups and 30 min behavioral coaching. FBT includes information regarding nutrition and physical activity, as well as behavior therapy skills, including parenting skills, self-monitoring, problem solving skills, motivation systems, emotional regulation, stress management, stimulus control, and relapse prevention.
Other Name: FBT

Experimental: Guided Self-Help Fam. Based Bx Treatment
The program includes information about diet and physical activity education, in addition to parent management skills and behavior therapy strategies in a guided self-help manual.
Behavioral: Guided Self-Help Fam. Based Bx Treatment
Treatment includes 14 20 minute visits over 6 months. gshFBT is delivered to parent/child dyads and includes the same content in the FBT groups but it is provided in a manual. The 20-minute visits focus on clarifying information in the manuals, collecting weight and self-monitoring logs, and problem solving any barriers to implementation.
Other Name: gshFBT




Primary Outcome Measures :
  1. Child weight loss [ Time Frame: Change from baseline to month 6, 12 and 18 ]
    BMI; BMIz

  2. Cost-effectiveness [ Time Frame: Baseline to month 6, 12 and 18 ]
    Cost per .1 BMIz change in child weight including health care costs, participant costs and treatment costs.


Secondary Outcome Measures :
  1. Parent BMI [ Time Frame: Change from baseline to month 6, 12 and 18 ]
    BMI

  2. Child Physical Activity - minutes of moderate-vigorous activity [ Time Frame: Change from baseline to month 6, 12 and 18 ]
    Measured by accelerometer, minutes in Moderate to Vigorous physical activity

  3. Parent Physical Activity - minutes of moderate-vigorous activity [ Time Frame: Change from baseline to month 6, 12 and 18 ]
    Measured by accelerometer, minutes in Moderate to Vigorous physical activity

  4. Child Nutrition-measured as servings of fruit and vegetables per day [ Time Frame: Change from baseline to month 6, 12 and 18 ]
    Self-reported number of servings of fruits and vegetables consumed each day

  5. Parent Nutrition-measured as servings of fruit and vegetables per day [ Time Frame: Change from baseline to month 6, 12 and 18 ]
    Self-reported number of servings of fruits and vegetables consumed each day



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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. An overweight child age 7-12, whose BMI is ≥ 85th percentile but does not meet criteria for severe obesity (i.e., BMI ≥120% of the 95th percentile or an absolute BMI ≥ 35 kg/m2 , whichever is lower for age and gender)
  2. The parent willing to participate can read English at a minimum of a 5th grade level
  3. Parent and Child willing to commit to attending all treatment and assessment sessions and be randomized to either treatment arm
  4. Child or parent is free from psychiatric illness than may affect participation;
  5. Child does not have any medical conditions that impact weight or may affect participation in physical activity or treatment
  6. Child is not taking medications that may impact their weight (unless medication dosage is stable and not for the purpose of impacting weight and appetite)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03096132


Contacts
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Contact: Takisha M Corbett, PhD 858-534-8088 chear@ucsd.edu
Contact: Kerri Boutelle, PhD 858-534-8037 kboutelle@ucsd.edu

Locations
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United States, California
UCSD Center for Healthy Eating and Activity Research (CHEAR) Recruiting
La Jolla, California, United States, 92093
Contact: Kerri N Boutelle, PhD    858-534-8037    kboutelle@ucsd.edu   
Principal Investigator: Kerri N Boutelle, PhD         
Sponsors and Collaborators
University of California, San Diego
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Kerri Boutelle, PhD UCSD

Publications:
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Responsible Party: Kerri Boutelle, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03096132     History of Changes
Other Study ID Numbers: 160289
R01DK108686 ( U.S. NIH Grant/Contract )
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kerri Boutelle, University of California, San Diego:
Obesity
Overweight
Overeating
Body Mass Index
Treatment
Intervention
Family Based Therapy
Weight
Children
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms