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Completed

NCT Number: NCT03096132

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

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.

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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSD Center for Healthy Eating and Activity Research (CHEAR)

La Jolla, California, 92093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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)
  • The parent willing to participate can read English at a minimum of a 5th grade level
  • Parent and Child willing to commit to attending all treatment and assessment sessions and be randomized to either treatment arm
  • Child or parent is free from psychiatric illness than may affect participation;
  • Child does not have any medical conditions that impact weight or may affect participation in physical activity or treatment
  • 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)

Treatment and study plan

Family Based Behavioral Treatment

Behavioral

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 names: FBT

Guided Self-Help Fam. Based Bx Treatment

Behavioral

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 names: gshFBT

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)

Registry information

Official study title

Effect of Treatment Dose on Childhood Obesity

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Mar 30, 2017
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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