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OverweightNCT01796067

Families Improving Together (FIT) for Weight Loss

A study testing Motivational and Family Weight Loss, Basic Health Education and Online Intervention in people with Overweight and Obese, run by University of South Carolina 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 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. Read more about this study

Who is it for?
Ages 11 to 16 years
Conditions the study is for
Overweight, Obese
What is being tested?
Motivational and Family Weight Loss, Basic Health Education and Online Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
241 participants
Where
1 siteUnited States
Study dates
Jul 2012to 8 Mar 2019
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 11 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Obesity Research Group

    Columbia, South Carolina, 29201

Other trials in United States

About this study

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.

Conditions
Overweight, Obese
Being tested
Motivational and Family Weight Loss, Basic Health Education, Online Intervention, Online Control
Keywords
Motivational intervention, Positive Parenting Intervention, Obesity, Physical Activity, Diet, African American, Adolescent
Medical subject headings
Overweight, Obesity, Motor Activity

What participants receive

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

  • Motivational and Family Weight LossBehavioural

    This group will receive the comprehensive motivational and family weight loss intervention.

  • Basic Health EducationBehavioural

    This group will receive the comprehensive basic health education intervention.

  • Online InterventionBehavioural

    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.

  • Online ControlBehavioural

    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.

Study groups in NCT01796067
Study groupRoleWhat they receive
Mot. & Fam. Weight Loss + Online Interv.ExperimentalParticipants are randomized to motivational and family weight loss program plus the online intervention.
Receives: Behavioral: Motivational and Family Weight Loss; Behavioral: Online Intervention
Mot. & Fam. Weight Loss + Online ControlExperimentalParticipants are randomized to motivational and family weight loss intervention and then the online control program.
Receives: Behavioral: Motivational and Family Weight Loss; Behavioral: Online Control
Basic Health Educ. & Online Interv.ExperimentalParticipants are randomized to the basic health education program and then the online intervention program.
Receives: Behavioral: Basic Health Education; Behavioral: Online Intervention
Basic Health Educ. & Online ControlActive comparatorParticipants are randomized to the basic health education program and then to the online control program.
Receives: Behavioral: Basic Health Education; Behavioral: Online Control

What is being measured

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

  1. Change in Body Mass Index (z-BMI) in Adolescents

    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.

    Measured: Baseline to 2 months

  2. Change in Body Mass Index (z-BMI) in Adolescents

    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.

    Measured: Baseline to 4 months

  3. Change in Body Mass Index (z-BMI) in Adolescents

    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.

    Measured: Baseline to 6-month follow-up

Secondary outcomes (7)
  1. Change in Moderate to Vigorous Physical Activity (MVPA) in Parents and Adolescents

    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.

    Measured: Baseline to 4 months

  2. Change of 24 Hour Dietary Recall (NDRS) of Kcals in Parents and Adolescents

    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.

    Measured: Baseline to 4 months

  3. Change in Psychosocial Variables in Adolescents

    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.

    Measured: Baseline to 4 months

  4. Change in Moderate to Vigorous Physical Activity in Adolescents

    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.

    Measured: Baseline to 6-month Follow-up

  5. Change of 24 Hour Dietary Recall (NDRS) of Kcals in Adolescents

    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.

    Measured: Baseline to 6-month Follow-up

  6. Change in Body Mass Index (z-BMI) in Parents

    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.

    Measured: Baseline to 4 months

  7. Change in Body Mass Index (z-BMI) for Parents

    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.

    Measured: Baseline to 6 Months Follow-up

Timeline

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

  1. First posted21 Feb 2013 (estimated)
  2. Study startJul 2012
  3. Primary completion8 Mar 2019
  4. Study completion8 Mar 2019

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
Factorial
Masking
None (open label)
Enrolment
241 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01796067
Sponsor's protocol ID
Pro00016136
Other IDs
R01HD072153
Status last verified
Apr 2019
First submitted
22 Jan 2013
Last updated
22 Apr 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Quattlebaum M, Sweeney AM, Wilson DK. Ecological predictors of family mealtime over time among overweight African American adolescent-parent dyads. J Behav Med. 2025 Aug;48(4):630-643. doi: 10.1007/s10865-025-00571-0. Epub 2025 May 15.

    PubMed 40374860
  • Kipp C, Wilson DK, Brown A, Quattlebaum M, Loncar H, Sweeney AM, Abshire DA. Compounding effects of stress on diet, physical activity, and wellbeing among African American parents: a qualitative study to inform the LEADS health promotion trial. J Behav Med. 2024 Aug;47(4):647-661. doi: 10.1007/s10865-024-00477-3. Epub 2024 Mar 9.

    PubMed 38460063
  • Sweeney AM, Wilson DK, Resnicow K, Van Horn ML, Kitzman H. Engagement With Tailored Physical Activity Content: Secondary Findings From the Families Improving Together for Weight Loss Randomized Controlled Trial. J Med Internet Res. 2023 Apr 12;25:e42581. doi: 10.2196/42581.

    PubMed 37043271
  • Brown A, Wilson DK, Sweeney AM, van Horn ML, Zarrett N, Pate RR. Buffering effects of protective factors on light and moderate-to-vigorous physical activity among african american women. J Behav Med. 2023 Jun;46(3):405-416. doi: 10.1007/s10865-022-00360-z. Epub 2022 Oct 19.

    PubMed 36260160
  • Loncar H, Wilson DK, Sweeney AM, Quattlebaum M, Zarrett N. Associations of parenting factors and weight related outcomes in African American adolescents with overweight and obesity. J Behav Med. 2021 Aug;44(4):541-550. doi: 10.1007/s10865-021-00208-y. Epub 2021 Mar 9.

    PubMed 33751355
  • Kipp C, Wilson DK, Sweeney AM, Zarrett N, Van Horn ML. Effects of Parenting and Perceived Stress on BMI in African American Adolescents. J Pediatr Psychol. 2021 Aug 19;46(8):980-990. doi: 10.1093/jpepsy/jsab025.

    PubMed 33738484
  • Brown A, Wilson DK, Sweeney AM, Van Horn ML. The Moderating Effects of Social Support and Stress on Physical Activity in African American Women. Ann Behav Med. 2021 Apr 7;55(4):376-382. doi: 10.1093/abm/kaaa051.

    PubMed 32692356
  • Sweeney AM, Wilson DK, Loncar H, Brown A. Secondary benefits of the families improving together (FIT) for weight loss trial on cognitive and social factors in African American adolescents. Int J Behav Nutr Phys Act. 2019 May 24;16(1):47. doi: 10.1186/s12966-019-0806-5.

    PubMed 31126345
  • Wilson DK, Sweeney AM, Law LH, Kitzman-Ulrich H, Resnicow K. Web-Based Program Exposure and Retention in the Families Improving Together for Weight Loss Trial. Ann Behav Med. 2019 Mar 20;53(4):399-404. doi: 10.1093/abm/kay047.

    PubMed 30892641
  • Wilson DK, Kitzman-Ulrich H, Resnicow K, Van Horn ML, St George SM, Siceloff ER, Alia KA, McDaniel T, Heatley V, Huffman L, Coulon S, Prinz R. An overview of the Families Improving Together (FIT) for weight loss randomized controlled trial in African American families. Contemp Clin Trials. 2015 May;42:145-57. doi: 10.1016/j.cct.2015.03.009. Epub 2015 Mar 30.

    PubMed 25835731

Questions about this trial

What is this clinical trial studying?

A study testing Motivational and Family Weight Loss, Basic Health Education and Online Intervention in people with Overweight and Obese, run by University of South Carolina 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?

The sponsor lists 8 inclusion and 4 exclusion criteria. 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 22 Apr 2019. 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?

Change in Body Mass Index (z-BMI) in Adolescents (time frame: Baseline to 2 months). The study lists 3 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 NCT01796067, which also lists 10 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 22 Apr 2019.

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