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OverweightNCT03096132

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

A study testing Family Based Behavioral Treatment and Guided Self-Help Fam. Based Bx Treatment in people with Overweight and Obesity, run by University of California, San Diego at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 12 years
Conditions the study is for
Overweight, Obesity
What is being tested?
Family Based Behavioral Treatment and Guided Self-Help Fam. Based Bx Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
151 participants
Where
1 siteUnited States
Study dates
18 Apr 2017to 3 Feb 2023
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
  • No healthy volunteers
  • Child
  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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCSD Center for Healthy Eating and Activity Research (CHEAR)

    La Jolla, California, 92093

Other trials in United States

About this study

Official title: Effect of Treatment Dose on Childhood Obesity

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.

Read the 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.

Conditions
Overweight, Obesity
Being tested
Family Based Behavioral Treatment, Guided Self-Help Fam. Based Bx Treatment
Keywords
Obesity, Overweight, Overeating, Body Mass Index, Treatment, Intervention, Family Based Therapy, Weight, Children
Medical subject headings
Overweight, Obesity, Hyperphagia, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Family Based Behavioral TreatmentBehavioural

    Also called FBT

    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.

  • Guided Self-Help Fam. Based Bx TreatmentBehavioural

    Also called gshFBT

    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.

Study groups in NCT03096132
Study groupRoleWhat they receive
Family Based Behavioral TreatmentActive comparatorThe program includes information about diet and physical activity education, in addition to parent management skills and behavior therapy strategies in a weekly group setting.
Receives: Behavioral: Family Based Behavioral Treatment
Guided Self-Help Fam. Based Bx TreatmentExperimentalThe 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.
Receives: Behavioral: Guided Self-Help Fam. Based Bx Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Child weight loss

    BMI; BMIz

    Measured: Change from baseline to month 6, 12 and 18

  2. Cost-effectiveness

    Cost per .1 BMIz change in child weight including health care costs, participant costs and treatment costs.

    Measured: Baseline to month 6, 12 and 18

Secondary outcomes (5)

  1. Parent BMI

    BMI

    Measured: Change from baseline to month 6, 12 and 18

  2. Child Physical Activity - minutes of moderate-vigorous activity

    Measured by accelerometer, minutes in Moderate to Vigorous physical activity

    Measured: Change from baseline to month 6, 12 and 18

  3. Parent Physical Activity - minutes of moderate-vigorous activity

    Measured by accelerometer, minutes in Moderate to Vigorous physical activity

    Measured: Change from baseline to month 6, 12 and 18

  4. Child Nutrition-measured as servings of fruit and vegetables per day

    Self-reported number of servings of fruits and vegetables consumed each day

    Measured: Change from baseline to month 6, 12 and 18

  5. Parent Nutrition-measured as servings of fruit and vegetables per day

    Self-reported number of servings of fruits and vegetables consumed each day

    Measured: Change from baseline to month 6, 12 and 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2017
  2. Study start18 Apr 2017
  3. Primary completion5 Jan 2023
  4. Study completion3 Feb 2023

Resources

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
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03096132
Sponsor's protocol ID
160289
Other IDs
R01DK108686
Status last verified
May 2023
First submitted
9 Mar 2017
Last updated
15 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Accurso EC, Norman GJ, Crow SJ, Rock CL, Boutelle KN. The role of motivation in family-based guided self-help treatment for pediatric obesity. Child Obes. 2014 Oct;10(5):392-9. doi: 10.1089/chi.2014.0023. Epub 2014 Sep 2.

    PubMed 25181608

  • Boutelle KN, Norman GJ, Rock CL, Rhee KE, Crow SJ. Guided self-help for the treatment of pediatric obesity. Pediatrics. 2013 May;131(5):e1435-42. doi: 10.1542/peds.2012-2204. Epub 2013 Apr 1.

    PubMed 23545372

Questions about this trial

What is this clinical trial studying?

A study testing Family Based Behavioral Treatment and Guided Self-Help Fam. Based Bx Treatment in people with Overweight and 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?

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 15 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?

Child weight loss (time frame: Change from baseline to month 6, 12 and 18). The study lists 2 primary outcomes in all. 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 NCT03096132, 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 15 May 2023.

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