Telehealth for Weight Maintenance of African-American Women ("Exercise Your Faith")
Telehealth for Weight Maintenance of African-American Women
調査の概要
詳細な説明
Rates of obesity in the United States have increased dramatically over the past four decades. Although research studies have demonstrated that weight loss is achievable through lifestyle modifications, the maintenance of weight reduction beyond six months remains a challenge.
This study will examine the feasibility of a telehealth program for weight maintenance. Telehealth is the delivery of health related services to promote healthy behaviors through the innovative use of technology, without the need for travel. The telehealth program will be accessible at home through Internet-enabled television sets. The telehealth program includes three components: (1) weekly video programs that discuss problem solving and relapse prevention strategies and include motivational stories; (2) regularly updated video exercise programs; and (3) online communication with other study participants and an exercise and nutrition specialist.
A randomized controlled trial will determine the feasibility and acceptability of the weight maintenance telehealth program. The study participants will be African-American women, as they have a higher prevalence of obesity with a disproportionate risk of related chronic diseases (e.g., diabetes). Two churches will collaborate with the University of Illinois at Chicago and assist in meeting the social, spiritual, and cultural needs of the participants. One hundred women will be recruited to participate in a one-year trial. The study includes a weight loss phase (Phase 1), and a weight maintenance phase (Phase 2). During Phase 1, all participants will attend a 12-week weight loss program held in the participating churches. Following completion of this program, one church will be assigned to be the intervention group, and the other church will be the comparison group. During Phase 2, participants in the intervention group will receive monthly telephone counseling plus access to the telehealth program, while the comparison group will only receive monthly telephone counseling. The specific aims of the study include: (1) to evaluate the effect of the telehealth program on change in body mass index; and (2) to evaluate the effect of the telehealth program on physical activity and fat, fiber, fruit and vegetable intake.
研究の種類
入学 (実際)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Self-identification as an African-American or Black woman
- Age 35-65 years
- Body mass index 25-50 kg/m2
- Physician approval to safely exercise if any positive answers on Physical Activity Readiness Questionnaire
- Owns a television
- Has a working telephone line
Exclusion Criteria:
- Plans to move from the Chicago area during the coming year
- Has a household member already in the study
- Uses illicit drugs or drinks more than two alcoholic drinks daily
- Pregnant, nursing, or planning pregnancy
- Participating in an organized weight loss program or using pharmacotherapy for weight loss
- Use an assistive device for ambulation, or cannot participate in exercise classes
研究計画
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
|
アクティブコンパレータ：Telephone Support Only
These participants receive telephone support only during the weight maintenance phase.
|
An initial 12-week weight loss program held in churches to ensure adequate participation, competence in performing exercises, and development of social relationships among participants.
All participants attend the church programs prior to the weight maintenance phase.
Following completion of the weight loss program, participants will receive monthly telephone counseling.
|
|
実験的：Telehealth
These participants receive telehealth support (with Internet-enabled digital video recorders) during the weight maintenance phase.
These participants also receive telephone support monthly.
|
An initial 12-week weight loss program held in churches to ensure adequate participation, competence in performing exercises, and development of social relationships among participants.
All participants attend the church programs prior to the weight maintenance phase.
Following completion of the weight loss program, participants will receive monthly telephone counseling.
After the weight loss program, women will access the home weight maintenance telehealth program through Internet enabled digital video recorders connected to their television sets.
The telehealth program includes three components: (1) Weekly Video: home access to weekly video programs including problem solving and relapse prevention strategies, as well as motivational stories; (2) Teleexercise: home access to updated video exercise programs; and (3) Electronic Communication: social support through online communication with other participants, and with an exercise and nutrition interventionist.
|
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 |
時間枠 |
|---|---|
|
ボディ・マス・インデックス
時間枠：12ヶ月
|
12ヶ月
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Physical activity
時間枠：12 months
|
12 months
|
|
|
Dietary intake
時間枠：12 months
|
Dietary intake includes fat, fiber, fruits and vegetables.
|
12 months
|
協力者と研究者
捜査官
- 主任研究者：Ben Gerber, MD, MPH、University of Illinois at Chicago
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
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。