Families Improving Together (FIT) for Weight Loss
2019年4月18日 更新者: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.
調査の概要
状態
完了
研究の種類
介入
入学 (実際)
241
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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South Carolina
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Columbia、South Carolina、アメリカ、29201
- Obesity Research Group
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
11年~16年 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:階乗代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的: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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実験的: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.
|
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実験的: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.
|
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アクティブコンパレータ: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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Body Mass Index (z-BMI) in Adolescents
時間枠: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
時間枠: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.
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Baseline to 4 months
|
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Change in Body Mass Index (z-BMI) in Adolescents
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Moderate to Vigorous Physical Activity (MVPA) in Parents and Adolescents
時間枠: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.
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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
時間枠: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.
|
Baseline to 4 months
|
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Change in Psychosocial Variables in Adolescents
時間枠: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.
|
Baseline to 4 months
|
|
Change in Moderate to Vigorous Physical Activity in Adolescents
時間枠: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
時間枠: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
時間枠: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
時間枠: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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
捜査官
- 主任研究者:Dawn K Wilson, PhD、University of South Carolina
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年7月1日
一次修了 (実際)
2019年3月8日
研究の完了 (実際)
2019年3月8日
試験登録日
最初に提出
2013年1月22日
QC基準を満たした最初の提出物
2013年2月18日
最初の投稿 (見積もり)
2013年2月21日
学習記録の更新
投稿された最後の更新 (実際)
2019年4月22日
QC基準を満たした最後の更新が送信されました
2019年4月18日
最終確認日
2019年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。