Interactive Mobile Messaging for Weight Control Among the Underserved (TRIMM)
Tailored Rapid Interactive Mobile Messaging (TRIMM) for Weight Control Among the Underserved
This project will test the efficacy of the "TRIMM" (Tailored Rapid Interactive Mobile Messaging) program, a user-friendly, semi-individualized text-messaging intervention to facilitate lifestyle change and weight loss among obese African-American adults with or at risk for diabetes, in a pilot, controlled clinical trial.
The text-messaging intervention will be in addition to, and compared with traditional diet, behavior, and physical activity education. Tips will be designed to increase knowledge, skills, and motivation.
調査の概要
詳細な説明
Type-2 diabetes, and its most important risk factor, obesity, have become major strains on our nation's health care system. By 2050, one in three U.S. adults could have diabetes (Stobbe, 2010), and obesity currently contributes nearly 17% of U.S. medical costs (Cawley, 2010). Our nation's underserved urban minority populations disproportionately suffer from type-2 diabetes and obesity. African-Americans, for example, comprise 12% of the US population but 23% of the extremely obese (Livingston, 2004). To reduce diabetes, obesity must be addressed. Unfortunately, traditional obesity interventions are intrusive and costly.
This project will test the efficacy of the "TRIMM" (Tailored Rapid Interactive Mobile Messaging) program, a user-friendly, semi-individualized text-messaging intervention to facilitate lifestyle change and weight loss among obese African-American adults with or at risk for diabetes, in a pilot, controlled clinical trial.
The text-messaging intervention will be in addition to, and compared with traditional diet, behavior, and physical activity education. Tips will be designed to increase knowledge, skills, and motivation. Participants will have the option to receive spiritually-based messages, if desired.
166 overweight or obese men and women will be recruited from 10 Baltimore inner-city churches, and will be assigned to one of two, six-month lifestyle-change programs. Participants must be overweight, aged 21-65, and own a cell phone with text-messaging capability. To be eligible for the study, participants will need to first pass a health screening and meet other study criteria.
The McKesson Foundation is funding this study, which has a total of 5 visits, ranging from ½ hr. to 3 hrs. The active intervention will last 6 months, with a follow-up visit at month 12. The TRIMM Program will feature periodic, individualized text messages and feedback via the participant's mobile phone as well as periodic follow-up appointments. The traditional program will consist of traditional diet, behavior, and physical activity education.
Qualified participants will receive individualized weight-loss plans and monetary compensation for their time, effort, & parking.
The long-term goal is to demonstrate, using a real-life setting, the potential superiority in efficacy of a specific mHealth application (text-messaging) for an underserved population at high risk of type-2 diabetes, compared to traditional, often more costly, and currently underutilized lifestyle-change interventions.
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:
- Participants must be African-American,
- aged 21-65,
- have a phone with unlimited text/SMS capability,
- a BMI > 27, and
- be free from uncontrolled hypertension or other health or mental health condition that would make it inappropriate or unsafe for them to participate.
Exclusion Criteria:
- Following initial assessments, participants will be excluded if they are currently abusing alcohol/other substances, or
- have an Inventory of Depressive Symptomatology (IDS-SR) score > 38 ('severe to very severe' depression).
Potential participants with uncontrolled hypertension (> 160 systolic or >95 diastolic), HbA1c > 8, or symptomatic CAD will be referred for medical clearance.
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
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：Standard Care
Individual assessment Lifestyle counseling
|
Individual assessment, lifestyle counseling
|
|
実験的：TRIMM Intervention
Individual assessment Lifestyle counseling Text messages
|
Individuals in the TRIMM arm receive daily, individualized text-messages promoting positive lifestyle changes to support weight loss/management.
|
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 |
|---|---|---|
|
Biometrics
時間枠：Change from month 0 (baseline) to month 3, 6, and 12
|
Physical measures: weight, blood pressure, resting heart rate, height, and waist circumference
|
Change from month 0 (baseline) to month 3, 6, and 12
|
|
Impact of Weight on Quality of Life
時間枠：Change from month 0 (baseline) to month 6
|
The Lite Version (IWQOL-Lite)is a widely used, well-validated, and reliable 31-item survey of obesity related quality of life (Kolotkin, 2002).
|
Change from month 0 (baseline) to month 6
|
|
Diet quality
時間枠：Change from month 0 (baseline) to month 6
|
The 2005 Healthy Eating Index (HEI-2005) is a standardized tool that measures diet quality compared to MyPyramid.gov
and the 2005 U.S. Dietary Guidelines.
The 24-hour dietary recall is used to calculate the 12 components of the HEI-2005.
HEI scores range from 0 to 100 (best) (USDA, 2000).
|
Change from month 0 (baseline) to month 6
|
|
Nutrition knowledge and beliefs.
時間枠：Change from month 0 (baseline) to month 6
|
The 2008 Health and Diet Survey (HDS) will be used to assess participant's knowledge and attitudes, important components of the Health Belief Model.
Questions cover nutrition knowledge and attitudes, grocery shopping, food label use, etc.
|
Change from month 0 (baseline) to month 6
|
|
Exercise Benefits/Barriers
時間枠：Change from month 0 (baseline) to month 6
|
The Exercise Benefits/Barriers Scale (EBBS).
This scale was developed to understand individuals' perceptions of the benefits of and barriers to participating in exercise.
|
Change from month 0 (baseline) to month 6
|
|
Self-Efficacy for Exercise
時間枠：Change from month 0 (baseline) to month 6
|
The Self-Efficacy for Exercise Scale (SEE) is a 13-item measure that focuses on self-efficacy and expectations related to the ability to continue to exercise in the face of barriers.
|
Change from month 0 (baseline) to month 6
|
|
Self-Efficacy for Weight Loss
時間枠：Change from month 0 (baseline) to month 6
|
Weight Efficacy Lifestyle Questionnaire (WEL).
This will be used to assess self-efficacy for weight loss.
The 20-item WEL consists of five situational factors: Negative Emotions, Availability, Social Pressure, Physical Discomfort, and Positive Activities.
|
Change from month 0 (baseline) to month 6
|
|
Motivation/Readiness to Change
時間枠：Change from month 0 (baseline) to month 6
|
University of Rhode Island Change Assessment Scale.
(URICA; McConnaughy, Prochaska, & Velicer, 1983).
This will be used to assess motivation and readiness to change; based on the Transtheoretical Model of health behavior change.
Accurately assessing motivation or commitment to change is a crucial step in matching patients to appropriate interventions.
|
Change from month 0 (baseline) to month 6
|
|
Depression
時間枠：Change from month 0 (baseline) to month 6
|
The Inventory of Depressive Symptomatology: Self-Report.
The DS-SR will be used to assess symptoms of depression (Rush, 1986, 1996).
Its psychometric properties have been established in various populations (Rush 1996, 2000).
|
Change from month 0 (baseline) to month 6
|
|
Barriers to Change
時間枠：Change from month 0 (baseline) to month 6
|
These will be examined using a measure specifically developed for use in this study.
Barriers assessed in the survey were identified via a focus group with the target population, existing literature on lifestyle change programs, and the investigators prior experience conducting health behavior change interventions.
|
Change from month 0 (baseline) to month 6
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Process survey
時間枠：month 6
|
Participants will be given a survey assessing intervention's ease of use, satisfaction and desire to continue use at 6 months to obtain process evaluation measures.
|
month 6
|
協力者と研究者
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 (実際)
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
本研究に関する用語
その他の研究ID番号
- 0003436
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。
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