- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01796067
Families Improving Together (FIT) for Weight Loss
18 kwietnia 2019 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
241
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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South Carolina
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Columbia, South Carolina, Stany Zjednoczone, 29201
- Obesity Research Group
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
11 lat do 16 lat (Dziecko)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przypisanie czynnikowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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Eksperymentalny: 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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Eksperymentalny: 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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Aktywny komparator: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Body Mass Index (z-BMI) in Adolescents
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Moderate to Vigorous Physical Activity (MVPA) in Parents and Adolescents
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
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Baseline to 4 months
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Change in Body Mass Index (z-BMI) for Parents
Ramy czasowe: Baseline to 6 Months Follow-up
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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 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Dawn K Wilson, PhD, University of South Carolina
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 lipca 2012
Zakończenie podstawowe (Rzeczywisty)
8 marca 2019
Ukończenie studiów (Rzeczywisty)
8 marca 2019
Daty rejestracji na studia
Pierwszy przesłany
22 stycznia 2013
Pierwszy przesłany, który spełnia kryteria kontroli jakości
18 lutego 2013
Pierwszy wysłany (Oszacować)
21 lutego 2013
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
22 kwietnia 2019
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
18 kwietnia 2019
Ostatnia weryfikacja
1 kwietnia 2019
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Pro00016136
- R01HD072153 (Grant/umowa NIH USA)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Motivational and Family Weight Loss
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University of California, San FranciscoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Zakończony
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The Miriam HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Rekrutacyjny
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Training and Implementation AssociatesRekrutacyjnyTradycyjny trening twarzą w twarz | Platforma Szkoleniowo-Wdrożeniowa Terapii Rodzin (FTTIP)Stany Zjednoczone
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University of PennsylvaniaAmerican Heart AssociationZakończonyChoroba wieńcowa | Zatrzymanie akcji serca | Czynniki ryzyka sercowo-naczyniowegoStany Zjednoczone