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Families Improving Together (FIT) for Weight Loss

18 avril 2019 mis à jour par: 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.

Aperçu de l'étude

Type d'étude

Interventionnel

Inscription (Réel)

241

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • South Carolina
      • Columbia, South Carolina, États-Unis, 29201
        • Obesity Research Group

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

11 ans à 16 ans (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation factorielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Mot. & Fam. Weight Loss + Online Interv.
Participants are randomized to motivational and family weight loss program plus the online intervention.
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.
Expérimental: Mot. & Fam. Weight Loss + Online Control
Participants are randomized to motivational and family weight loss intervention and then the online control program.
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.
Expérimental: Basic Health Educ. & Online Interv.
Participants are randomized to the basic health education program and then the online intervention program.
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.
Comparateur actif: Basic Health Educ. & Online Control
Participants are randomized to the basic health education program and then to the online control program.
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Body Mass Index (z-BMI) in Adolescents
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Moderate to Vigorous Physical Activity (MVPA) in Parents and Adolescents
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Dawn K Wilson, PhD, University of South Carolina

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juillet 2012

Achèvement primaire (Réel)

8 mars 2019

Achèvement de l'étude (Réel)

8 mars 2019

Dates d'inscription aux études

Première soumission

22 janvier 2013

Première soumission répondant aux critères de contrôle qualité

18 février 2013

Première publication (Estimation)

21 février 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 avril 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 avril 2019

Dernière vérification

1 avril 2019

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Pro00016136
  • R01HD072153 (Subvention/contrat des NIH des États-Unis)

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