Families Improving Together (FIT) for Weight Loss

April 18, 2019 updated by: Dawn Wilson, University of South Carolina
The increasing rate of obesity has become a major public health concern with national reports indicating 40% of African American adolescents are now overweight/obese. Little is known about effective weight loss interventions in ethnic minority adolescents. However, research has shown that ethnic minorities attend fewer intervention sessions, have higher attrition rates and lose less weight compared to Caucasians. Two fundamental problems related to this lack of progress are 1) lack of appropriate content of weight loss interventions for African American adolescents that integrate cultural issues, parenting skills, and motivational strategies for long-term change and, 2) poor dose of weight loss interventions because of participant fatigue and drop out. While previous weight loss studies for adolescents have been long lasting (12-25 weeks), our team developed a weight loss program that is a relatively brief (8-week) face-to-face intervention that integrates motivational (autonomy-support) and positive parenting skills (monitoring, social support, positive communication skills) for reducing z-BMI in overweight African American adolescents. Our team recently conducted a pilot study testing the feasibility of an 8-week on-line culturally tailored intervention, Thus, the goal of this project is to conduct a randomized controlled efficacy trial to address the problems with past studies by 1) making the face-to-face group intervention shorter, 2) using an on-line component to compliment the group-based intervention for increasing dose, and by 3) tailoring a motivational and parenting skills program directly to parents and adolescents skill levels and cultural background. 520 overweight African American adolescents and their parents will be recruited to participate. Phase I of the trial will test the efficacy of an 8-week face-to-face group randomized trial comparing motivational plus family-based weight loss (M+FWL) to a basic health (BH) education program on reducing z-BMI and improving diet and physical activity (PA) in overweight African American adolescents. In phase II of the trial participants will be re-randomized to either an 8-week on-line intervention or a control on-line program resulting in a 2 (M+FWL vs. BH group) x 2 (intervention vs. control on-line program) factorial design. A 6-month follow-up will examine whether adolescents in the 8-week M+FWL group plus 8-week on-line intervention program will show the greatest maintenance in reducing z-BMI.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
241

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Obesity Research Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must have a parent or primary caregiver who lives in the same house as the adolescent
  • Live within 60 miles of the program's office
  • Have at least 3 grandparents who are African American
  • Access to the internet
  • Children between the ages of 11 and 16
  • Child must have BMI above 85th percentile and below 99th percentile
  • Have no medical condition that would limit participation in moderate intensity exercise including life-threatening illness (e.g., immobile, severely disabled, or bed ridden)
  • Available and able to participate in measures and intervention activities over the next year

Exclusion Criteria:

  • Adolescents with chronic illness
  • Adolescents who require a specialized diet may not be eligible
  • Developmental delay
  • Partaking currently in another weight loss program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mot. & Fam. Weight Loss + Online Interv.
Participants are randomized to motivational and family weight loss program plus the online intervention.
Behavioral: Motivational and Family Weight Loss
This group will receive the comprehensive motivational and family weight loss intervention.
Behavioral: Online Intervention
Participants will receive the online tailored weight loss intervention program after they have either received the motivational plus family weight loss program or basic health face-to-face program.
Experimental: Mot. & Fam. Weight Loss + Online Control
Participants are randomized to motivational and family weight loss intervention and then the online control program.
Behavioral: Motivational and Family Weight Loss
This group will receive the comprehensive motivational and family weight loss intervention.
Behavioral: Online Control
Participants will receive the online control program after they have either received the motivational plus family weight loss program or the basic health education program.
Experimental: Basic Health Educ. & Online Interv.
Participants are randomized to the basic health education program and then the online intervention program.
Behavioral: Online Intervention
Participants will receive the online tailored weight loss intervention program after they have either received the motivational plus family weight loss program or basic health face-to-face program.
Behavioral: Basic Health Education
This group will receive the comprehensive basic health education intervention.
Active Comparator: Basic Health Educ. & Online Control
Participants are randomized to the basic health education program and then to the online control program.
Behavioral: Online Control
Participants will receive the online control program after they have either received the motivational plus family weight loss program or the basic health education program.
Behavioral: Basic Health Education
This group will receive the comprehensive basic health education intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Body Mass Index (z-BMI) in Adolescents
Time Frame: Baseline to 2 months
We are investigating whether there is change in body mass index (BMI; age- and sex-adjusted based upon CDC norms) from baseline to 2 months and whether there are group differences (i.e., M+FWL vs. BH groups) in change in BMI in adolescents.
Baseline to 2 months
Change in Body Mass Index (z-BMI) in Adolescents
Time Frame: Baseline to 4 months
We are investigating whether there is change in body mass index (BMI; age- and sex-adjusted based upon CDC norms) from baseline to 4 months and whether there are group differences (i.e., M+FWL & Intervention online, M+FWL & Control online, BH & Intervention online, BH & Control online) in change in BMI in adolescents.
Baseline to 4 months
Change in Body Mass Index (z-BMI) in Adolescents
Time Frame: Baseline to 6-month follow-up
We are investigating intervention effects on change in body mass index (BMI; age- and sex-adjusted based upon CDC norms) from baseline to 6 months post-intervention. Specifically, we will examine whether there are group differences (i.e., M+FWL & Intervention online, M+FWL & Control online, BH & Intervention online, BH & Control online) in maintenance in BMI in adolescents.
Baseline to 6-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Moderate to Vigorous Physical Activity (MVPA) in Parents and Adolescents
Time Frame: Baseline to 4 months
Minutes per day; We are investigating whether there is change of physical activity from baseline to 4 months and whether there are group differences (i.e., M+FWL & Intervention online, M+FWL & Control online, BH & Intervention online, BH & Control online) in change in MVPA in parents and adolescents.
Baseline to 4 months
Change of 24 Hour Dietary Recall (NDRS) of Kcals in Parents and Adolescents
Time Frame: Baseline to 4 months
We are investigating whether there is change of Kcals at 4 months. We are looking at these effects for fruit and vegetable intake, as well as total fat intake and whether there are group differences (i.e., M+FWL & Intervention online, M+FWL & Control online, BH & Intervention online, BH & Control online) in change in diet in parents and adolescents.
Baseline to 4 months
Change in Psychosocial Variables in Adolescents
Time Frame: Baseline to 4 months
Examine the effects of psychosocial variables (autonomy-support, monitoring, communication) as potential mediators of the intervention effects on changes in z-BMI, dietary intake, and MVPA in adolescents.
Baseline to 4 months
Change in Moderate to Vigorous Physical Activity in Adolescents
Time Frame: Baseline to 6-month Follow-up
Minutes per day; We are investigating whether there is change of physical activity at the 6-month follow-up and whether there are group differences (i.e., M+FWL & Intervention online, M+FWL & Control online, BH & Intervention online, BH & Control online) in change in MVPA in adolescents.
Baseline to 6-month Follow-up
Change of 24 Hour Dietary Recall (NDRS) of Kcals in Adolescents
Time Frame: Baseline to 6-month Follow-up
We are investigating whether there is change of Kcals at 6-month follow-up. We are specifically looking at effects for fruit and vegetable intake, as well as total fat intake in adolescents, and vegetable intake, as well as total fat intake and whether there are group differences (i.e., M+FWL & Intervention online, M+FWL & Control online, BH & Intervention online, BH & Control online) in change in diet in adolescents.
Baseline to 6-month Follow-up
Change in Body Mass Index (z-BMI) in Parents
Time Frame: Baseline to 4 months
We are investigating whether there is change in body mass index (BMI; age- and sex-adjusted based upon CDC norms) from baseline to 4 months and whether there are group differences (i.e., M+FWL & Intervention online, M+FWL & Control online, BH & Intervention online, BH & Control online) in change in BMI in parents.
Baseline to 4 months
Change in Body Mass Index (z-BMI) for Parents
Time Frame: Baseline to 6 Months Follow-up
We are investigating whether there is change in body mass index (BMI; age- and sex-adjusted based upon CDC norms) from baseline to 6 months and whether there are group differences (i.e., M+FWL & Intervention online, M+FWL & Control online, BH & Intervention online, BH & Control online) in change in BMI in parents.
Baseline to 6 Months Follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Michigan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dawn K Wilson, PhD, University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 8, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 8, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00016136
  • R01HD072153 (U.S. NIH Grant/Contract)

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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