- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01796067
Families Improving Together (FIT) for Weight Loss
18. dubna 2019 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Typ studie
Intervenční
Zápis (Aktuální)
241
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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South Carolina
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Columbia, South Carolina, Spojené státy, 29201
- Obesity Research Group
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
11 let až 16 let (Dítě)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Faktorové přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Mot. & Fam. Weight Loss + Online Interv.
Participants are randomized to motivational and family weight loss program plus the online intervention.
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This group will receive the comprehensive motivational and family weight loss 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.
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Experimentální: Mot. & Fam. Weight Loss + Online Control
Participants are randomized to motivational and family weight loss intervention and then the online control program.
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This group will receive the comprehensive motivational and family weight loss intervention.
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.
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Experimentální: Basic Health Educ. & Online Interv.
Participants are randomized to the basic health education program and then the online intervention program.
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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.
This group will receive the comprehensive basic health education intervention.
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Aktivní komparátor: Basic Health Educ. & Online Control
Participants are randomized to the basic health education program and then to the online control program.
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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.
This group will receive the comprehensive basic health education intervention.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Body Mass Index (z-BMI) in Adolescents
Časové okno: Baseline to 2 months
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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.
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Baseline to 2 months
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Change in Body Mass Index (z-BMI) in Adolescents
Časové okno: Baseline to 4 months
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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.
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Baseline to 4 months
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Change in Body Mass Index (z-BMI) in Adolescents
Časové okno: Baseline to 6-month follow-up
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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.
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Baseline to 6-month follow-up
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Moderate to Vigorous Physical Activity (MVPA) in Parents and Adolescents
Časové okno: Baseline to 4 months
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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.
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Baseline to 4 months
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Change of 24 Hour Dietary Recall (NDRS) of Kcals in Parents and Adolescents
Časové okno: Baseline to 4 months
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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.
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Baseline to 4 months
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Change in Psychosocial Variables in Adolescents
Časové okno: Baseline to 4 months
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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.
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Baseline to 4 months
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Change in Moderate to Vigorous Physical Activity in Adolescents
Časové okno: Baseline to 6-month Follow-up
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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.
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Baseline to 6-month Follow-up
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Change of 24 Hour Dietary Recall (NDRS) of Kcals in Adolescents
Časové okno: 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.
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Baseline to 6-month Follow-up
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Change in Body Mass Index (z-BMI) in Parents
Časové okno: 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
|
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Change in Body Mass Index (z-BMI) for Parents
Časové okno: 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.
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Baseline to 6 Months Follow-up
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Dawn K Wilson, PhD, University of South Carolina
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. července 2012
Primární dokončení (Aktuální)
8. března 2019
Dokončení studie (Aktuální)
8. března 2019
Termíny zápisu do studia
První předloženo
22. ledna 2013
První předloženo, které splnilo kritéria kontroly kvality
18. února 2013
První zveřejněno (Odhad)
21. února 2013
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
22. dubna 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
18. dubna 2019
Naposledy ověřeno
1. dubna 2019
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Pro00016136
- R01HD072153 (Grant/smlouva NIH USA)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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