Family PALS (PArtners in Lifestyle Support) (PALS)
Family Diabetes Study (Family PALS (PArtners in Lifestyle Support)
NOTE: This study is in the trial-phase of a 5-year study that included a formative research phase (Phase 1 - IRB study # 07-1765 "Family-based Diabetes Self-management Training for African American Adults"). During the first phase, eight focus groups were conducted with 68 participants and a validation study with 215 African American patients with type 2 diabetes. The data gathered in Phase 1 informs the refinement of the intervention in this phase.
Purpose: The overall goal of this research is to evaluate, in a randomized controlled trial, a family-based diabetes self-management intervention for overweight/obese African American adults with type 2 diabetes (the "index participants") and a paired overweight family member (co-participant) who does not have diabetes. The primary outcome is weight change in the index participant.
調査の概要
詳細な説明
Type 2 diabetes disproportionately burdens African Americans, and already excessive rates of diabetes are expected to increase even further as rates of obesity rise. While there is evidence that diabetes self-management training is effective in improving metabolic control, and modest weight loss can delay the onset of diabetes, the investigators have limited knowledge of the best approach to self-management training from a family perspective in high risk groups such as African Americans. Family remains a valued dimension of African American life and may be an important behavioral context for interventions to improve disease management and health outcomes. Nonetheless, there are no trials of family-based interventions to improve diabetes self-care and achieve weight loss that have involved adult families.
Participants: A total of 80 pairs (index participant + family member) or 160 adults will participate in this trial where a 20-session behavioral weight loss intervention will be tested. Participants include overweight or obese African Americans with type 2 diabetes and a paired co-participant identified as an overweight or obese adult family member without type 2 diabetes. Family members may self-describe as non-African Americans.
Procedures (methods): Study participants will be enrolled in a randomized controlled trial using a 2:1 random allocation to the special intervention (a 20-session family-based behavioral weight loss intervention) or a usual care group (controls). Following the trial, participants in the usual care group will receive a 6-session weight management intervention (over a 2-month period) based on the 20-session special intervention.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27599-7426
- UNC Center for Health Promotion and Disease Prevention (HPDP)
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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
Person with diabetes.
Inclusion Criteria:
- self-described African American 21-75 years of age;
- self-reported diagnosis of type 2 diabetes;
- A1c value ≤ 11%;
- currently under the care of a physician or other health care provider;
- able to participate in moderate level physical activity;
- willing to lose 5% or more of initial body weight and follow recommendations for healthy dietary and physical activity patterns;
- access to a phone and willing to complete a telephone-administered survey;
- English speaking.
Exclusion Criteria:
- any medical contraindication to weight loss;
- cardiovascular event within the past 6 months;
- evidence of active cancer diagnosis;
- pregnant or lactating;
- self-reported history of renal disease other than kidney stones;
- any history of gastric bypass surgery or scheduled surgery for this purpose;
- weight loss of >20 lbs in the last 3 months;
- current use of medications for weight loss, treatment of psychosis or manic-depressive illness.
Family Members: Inclusion criteria (NOTE: 'Family' for this study is defined as 'a group of intimates living together or in close proximity with strong emotional bonds (identification, attachment, loyalty, reciprocity, solidarity), and with strong, ongoing personal ties. Family members can only participate if paired with an African American study participant.):
- 21 -75 years of age;
- living with or married (for at least 1 year) to an African American adult diagnosed with diabetes;
- self-described as a blood relative of an African American with diabetes with whom there is regular, ongoing contact;
- overweight/obesity defined as a BMI between 25 to 47, inclusive;
- English-speaking;
- able to participate in moderate level physical activity;
- willing to lose 5% or more of initial body weight and follow recommendations for healthy dietary and physical activity patterns;
- access to a phone and willing to complete a telephone-administered survey.
Exclusion Criteria:
- self-reported diagnosis of type 2 diabetes (the A1c test used in this study cannot be used for diagnostic purposes; additionally, the initial therapy of most newly diagnosed patients with type 2 diabetes includes lifestyle changes and weight loss);
- any medical contraindication to weight loss;
- cardiovascular event within the past 6 months;
- evidence of active cancer diagnosis;
- pregnant or lactating;
- self-reported history of renal disease other than kidney stones;
- any history of gastric bypass surgery or scheduled surgery for this purpose;
- weight loss of > 20 lbs in the last 3 months;
- current use of medications for weight loss, treatment of psychosis or manic-depressive illness.
Family members do not themselves have to be self-described African Americans.
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：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：Family-based intervention
Special intervention (20 weekly group-based sessions) to be compared with a delayed intervention control group.
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Participants assigned to the experimental group will begin the 2o-week weight loss intervention, while delayed intervention controls will wait until the end of this period to begin their program.
The weight loss intervention includes 20 weekly group-based sessions facilitated by a registered dietitian.
Each group session will last about 120 minutes and include: weight check, group sharing and problem-solving, discussion of a weight control topics (nutrition, physical activity, or behavior change), physical activity and/or taste-testing.
Ten sessions will include a brief component, focused on improving family relationships for better diabetes self-care.
The study weight loss goal is ≥10 pounds (minimum rate-0.5 lb/week; maximum-2 lbs/week).
While the control group waits, they will receive 1 newsletter with study updates and general health or diabetes information.
The delayed intervention includes 6 sessions (4 weekly + 2 bi-weekly) following the same format as the experimental group.
他の名前：
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他の：Delayed intervention controls
The delayed intervention controls will continue with usual care (if patients with diabetes)and at the end of the experimental period (6 months), they will receive a 6-session weight loss intervention delivered over a 2 month period.
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Participants assigned to the experimental group will begin the 2o-week weight loss intervention, while delayed intervention controls will wait until the end of this period to begin their program.
The weight loss intervention includes 20 weekly group-based sessions facilitated by a registered dietitian.
Each group session will last about 120 minutes and include: weight check, group sharing and problem-solving, discussion of a weight control topics (nutrition, physical activity, or behavior change), physical activity and/or taste-testing.
Ten sessions will include a brief component, focused on improving family relationships for better diabetes self-care.
The study weight loss goal is ≥10 pounds (minimum rate-0.5 lb/week; maximum-2 lbs/week).
While the control group waits, they will receive 1 newsletter with study updates and general health or diabetes information.
The delayed intervention includes 6 sessions (4 weekly + 2 bi-weekly) following the same format as the experimental group.
他の名前：
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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 |
|---|---|---|
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Change in body weight
時間枠：6 months
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Change in weight from start to end of the 20-weekly group-based intervention.
NOTE: Weekly sessions are not held during weeks where holidays occur on a scheduled session date (such that the duration of the intervention may be more than 20 weeks).
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6 months
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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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Effect on Hemoglobin A1c
時間枠：6 months (post-intervention)
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A1c change from enrollment to post-intervention.
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6 months (post-intervention)
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Lifestyle behaviors
時間枠：6 months
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Diet and physical activity behavior changes (from enrollment or baseline to post-intervention)
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6 months
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Blood pressure change
時間枠：6 months
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Change in systolic and diastolic blood pressure from baseline (enrollment) to post-intervention
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6 months
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Change in psychosocial factors
時間枠：6 months
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Changes in measures of family functioning, social support and social relationships, self-efficacy, perceived barriers to diabetes self-care, and quality of life; comparing baseline to post-intervention.
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6 months
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協力者と研究者
捜査官
- 主任研究者：Carmen D. Samuel-Hodge, PhD、University of North Carolina, Chapel Hill
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
本研究に関する用語
その他の研究ID番号
- 10-1449
- K01DK080079 (米国 NIH グラント/契約)
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。