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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Mot. & Fam. Weight Loss + Online Interv. | Experimental | Participants 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 Control | Experimental | Participants 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. | Experimental | Participants 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 Control | Active comparator | Participants 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.
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
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
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)
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
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
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
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
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
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
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.
- First posted21 Feb 2013 (estimated)
- Study startJul 2012
- Primary completion8 Mar 2019
- Study completion8 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Dawn Wilson, University of South Carolina
- Investigators
- Dawn K Wilson, PhD, Principal investigator, University of South Carolina
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 40374860Kipp 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 38460063Sweeney 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 37043271Brown 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 36260160Loncar 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 33751355Kipp 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 33738484Brown 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 32692356Sweeney 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 31126345Wilson 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 30892641Wilson 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Families Improving Together (FIT) for Weight Loss
- ClinicalTrials.gov ID
- NCT01796067
- Acronym / sponsor ID
- Pro00016136
- Conditions
- Overweight, Obese
- Keywords
- Motivational intervention, Positive Parenting Intervention, Obesity, Physical Activity, Diet, African American, Adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- University of Michigan, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jul 2012
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 21 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mot. & Fam. Weight Loss + Online Interv. | Experimental | Behavioral: Motivational and Family Weight Loss, Behavioral: Online InterventionParticipants are randomized to motivational and family weight loss program plus the online intervention. |
| Mot. & Fam. Weight Loss + Online Control | Experimental | Behavioral: Motivational and Family Weight Loss, Behavioral: Online ControlParticipants are randomized to motivational and family weight loss intervention and then the online control program. |
| Basic Health Educ. & Online Interv. | Experimental | Behavioral: Basic Health Education, Behavioral: Online InterventionParticipants are randomized to the basic health education program and then the online intervention program. |
| Basic Health Educ. & Online Control | Active comparator | Behavioral: Basic Health Education, Behavioral: Online ControlParticipants are randomized to the basic health education program and then to the online control program. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- Adolescents with chronic illness
- Adolescents who require a specialized diet may not be eligible
- Developmental delay
- Partaking currently in another weight loss program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational and Family Weight LossThis group will receive the comprehensive motivational and family weight loss intervention. | Behavioural | Mot. & Fam. Weight Loss + Online Control, Mot. & Fam. Weight Loss + Online Interv. |
| Basic Health EducationThis group will receive the comprehensive basic health education intervention. | Behavioural | Basic Health Educ. & Online Control, Basic Health Educ. & Online Interv. |
| Online InterventionParticipants 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. | Behavioural | Basic Health Educ. & Online Interv., Mot. & Fam. Weight Loss + Online Interv. |
| Online ControlParticipants will receive the online control program after they have either received the motivational plus family weight loss program or the basic health education program. | Behavioural | Basic Health Educ. & Online Control, Mot. & Fam. Weight Loss + Online Control |
Primary outcome
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.
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.
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.
7 secondary outcomes
Change in Moderate to Vigorous Physical Activity (MVPA) in Parents and Adolescents
Time frame: Baseline to 4 months
Change of 24 Hour Dietary Recall (NDRS) of Kcals in Parents and Adolescents
Time frame: Baseline to 4 months
Change in Psychosocial Variables in Adolescents
Time frame: Baseline to 4 months
Change in Moderate to Vigorous Physical Activity in Adolescents
Time frame: 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
Change in Body Mass Index (z-BMI) in Parents
Time frame: Baseline to 4 months
Change in Body Mass Index (z-BMI) for Parents
Time frame: Baseline to 6 Months Follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Derived from this study: PubMed 40374860Quattlebaum 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.
- Derived from this study: PubMed 38460063Kipp 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.
- Derived from this study: PubMed 37043271Sweeney 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.
- Derived from this study: PubMed 36260160Brown 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.
- Derived from this study: PubMed 33751355Loncar 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.
- Derived from this study: PubMed 33738484Kipp 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.
- Derived from this study: PubMed 32692356Brown 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.
- Derived from this study: PubMed 31126345Sweeney 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.
- Derived from this study: PubMed 30892641Wilson 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.
- Derived from this study: PubMed 25835731Wilson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn K Wilson, PhD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
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.