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治験 NCT06724406 (FAM WEL B-ing)（対象：Obesity and Overweight、糖尿病、体重減少、Behavior Change）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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ノースカロライナ大学チャペルヒル校FAMily-centered WEight Loss for Black Adults (FAM WEL B-ing)
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06724406 (FAM WEL B-ing) は 介入研究 臨床試験 で、Obesity and Overweight、糖尿病、体重減少、Behavior Change に関するものです。現在は 募集中 で、2025年2月3日 から開始しています。256 名の参加者 の募集が計画されています。この治験は ノースカロライナ大学チャペルヒル校 によって主催され、2028年12月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年8月29日 です。
概要
The goal of this clinical trial is to learn the best combination of family components that yields optimal weight loss among Black adults. The main question it aims to answer is:
What combination of four family components in combination with a standard behavioral weight loss program yields optimal weight loss among Black adults? Researchers will compare different combinations of family skills components (communication content, cohesion content, number of sessions, and mode of delivery) to see the best weight loss.
Participants will:
- Participate in a 6-month behavioral weight loss intervention
- Attend core weight loss in-person group sessions, and dyad based family sessions
- Keep track of weight, dietary intake and physical activity
詳細説明
This clinical trial aims to determine the most effective combination of family components to achieve optimal weight loss among Black adults. The main focus is to assess how different combinations of four family skills components-communication content, cohesion content, number of sessions, and mode of delivery-work together with a standard behavioral weight loss program.
Participants will engage in a 6-month behavioral weight loss intervention, which includes attending group weight loss sessions and family-based dyad sessions. They will also track their weight, dietary intake, and physical activity.
This is a 2 x4 factorial design with 16 study conditions.
公式タイトル
FAMily-centered WEight Loss for Black Adults (FAM WEL B-ing): Optimization and Evaluation Using Multiphase Optimization Strategy (MOST) and Social Network Analysis (SNA)
疾患／病気
Obesity and Overweight糖尿病体重減少Behavior Changeその他の研究識別子
- FAM WEL B-ing
- 24-1302
- R61HL169357 (米国NIHの助成金/契約)
NCT番号
開始日
2025-02-03
最終更新日
2025-08-29
終了予定日
2028-12-31
目標参加者数
256
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
weight loss program
African American or Black families
nutrition and physical activity behavior change
African American or Black families
nutrition and physical activity behavior change
主目的
治療
割付方法
無作為化
介入モデル
ファクトリアル割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Session 5, In-Person, Communication and Cohesion Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering communication and cohesion | Family Skills Training Session Quantity: 5 The number of family skills training sessions administered: 5 sessions Family Skills Training Session Mode: In-person The mode of administration of family skills training sessions: in person or online Family Skills Training Content: Communication The content of family skills training sessions administered focused on communication and conflict resolution : communication and conflict resolution Family Skills Training Content: Cohesion The content of family skills training sessions administered focused on cohesion: cohesion or no cohesion |
実験的Session 5, In-Person, Communication and No Cohesion Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering communication but no cohesion | Family Skills Training Session Quantity: 5 The number of family skills training sessions administered: 5 sessions Family Skills Training Session Mode: In-person The mode of administration of family skills training sessions: in person or online Family Skills Training Content: Communication The content of family skills training sessions administered focused on communication and conflict resolution : communication and conflict resolution Family Skills Training Content: No Cohesion The content of family skills training sessions administered focused on cohesion: no cohesion |
実験的Session 5, In-Person, Cohesion and No Communication Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering cohesion but no communication | Family Skills Training Session Quantity: 5 The number of family skills training sessions administered: 5 sessions Family Skills Training Session Mode: In-person The mode of administration of family skills training sessions: in person or online Family Skills Training Content: Cohesion The content of family skills training sessions administered focused on cohesion: cohesion or no cohesion |
実験的Session 5, In-Person, No Communication and No Cohesion Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering no communication but no cohesion | Family Skills Training Session Quantity: 5 The number of family skills training sessions administered: 5 sessions Family Skills Training Session Mode: In-person The mode of administration of family skills training sessions: in person or online Family Skills Training Content: Communication The content of family skills training sessions administered focused on communication and conflict resolution : communication and conflict resolution Family Skills Training Content: Cohesion The content of family skills training sessions administered focused on cohesion: cohesion or no cohesion Family Skills Training Content: No Communication The content of family skills training sessions administered focused on communication and conflict resolution : no communication and conflict resolution |
実験的Session 5, On-Line, Communication and Cohesion Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering communication and cohesion | Family Skills Training Session Quantity: 5 The number of family skills training sessions administered: 5 sessions Family Skills Training Content: Communication The content of family skills training sessions administered focused on communication and conflict resolution : communication and conflict resolution Family Skills Training Content: Cohesion The content of family skills training sessions administered focused on cohesion: cohesion or no cohesion Family Skills Training Session Mode: Online The mode of administration of family skills training sessions: online |
実験的Session 5, On-Line, Communication and No Cohesion Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering communication but no cohesion | Family Skills Training Session Quantity: 5 The number of family skills training sessions administered: 5 sessions Family Skills Training Content: Communication The content of family skills training sessions administered focused on communication and conflict resolution : communication and conflict resolution Family Skills Training Session Mode: Online The mode of administration of family skills training sessions: online Family Skills Training Content: No Cohesion The content of family skills training sessions administered focused on cohesion: no cohesion |
実験的Session 5, On-Line, Cohesion and No Communication Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering cohesion but no communication | Family Skills Training Session Quantity: 5 The number of family skills training sessions administered: 5 sessions Family Skills Training Content: Cohesion The content of family skills training sessions administered focused on cohesion: cohesion or no cohesion Family Skills Training Session Mode: Online The mode of administration of family skills training sessions: online Family Skills Training Content: No Communication The content of family skills training sessions administered focused on communication and conflict resolution : no communication and conflict resolution |
実験的Session 5, On-Line, No Communication and No Cohesion Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering no communication and no cohesion | Family Skills Training Session Quantity: 5 The number of family skills training sessions administered: 5 sessions Family Skills Training Session Mode: Online The mode of administration of family skills training sessions: online Family Skills Training Content: No Communication The content of family skills training sessions administered focused on communication and conflict resolution : no communication and conflict resolution Family Skills Training Content: No Cohesion The content of family skills training sessions administered focused on cohesion: no cohesion |
実験的Session 10, In-Person, Communication and Cohesion Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering communication and cohesion | Family Skills Training Session Mode: In-person The mode of administration of family skills training sessions: in person or online Family Skills Training Content: Communication The content of family skills training sessions administered focused on communication and conflict resolution : communication and conflict resolution Family Skills Training Content: Cohesion The content of family skills training sessions administered focused on cohesion: cohesion or no cohesion Family Skills Training Session Quantity: 10 The number of family skills training sessions administered: 10 sessions |
実験的Session 10, In-Person, Communication and No Cohesion Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering communication but no cohesion | Family Skills Training Session Mode: In-person The mode of administration of family skills training sessions: in person or online Family Skills Training Content: Communication The content of family skills training sessions administered focused on communication and conflict resolution : communication and conflict resolution Family Skills Training Session Quantity: 10 The number of family skills training sessions administered: 10 sessions Family Skills Training Content: No Cohesion The content of family skills training sessions administered focused on cohesion: no cohesion |
実験的Session 10, In-Person, Cohesion and No Communication Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering cohesion but no no communication | Family Skills Training Session Mode: In-person The mode of administration of family skills training sessions: in person or online Family Skills Training Content: Cohesion The content of family skills training sessions administered focused on cohesion: cohesion or no cohesion Family Skills Training Session Quantity: 10 The number of family skills training sessions administered: 10 sessions Family Skills Training Content: No Communication The content of family skills training sessions administered focused on communication and conflict resolution : no communication and conflict resolution |
実験的Session 10, In-Person, No Communication and No Cohesion Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering no communication and no cohesion | Family Skills Training Session Mode: In-person The mode of administration of family skills training sessions: in person or online Family Skills Training Session Quantity: 10 The number of family skills training sessions administered: 10 sessions Family Skills Training Content: No Communication The content of family skills training sessions administered focused on communication and conflict resolution : no communication and conflict resolution Family Skills Training Content: No Cohesion The content of family skills training sessions administered focused on cohesion: no cohesion |
実験的Session 10, On-Line, Communication and Cohesion Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering communication and cohesion | Family Skills Training Content: Communication The content of family skills training sessions administered focused on communication and conflict resolution : communication and conflict resolution Family Skills Training Content: Cohesion The content of family skills training sessions administered focused on cohesion: cohesion or no cohesion Family Skills Training Session Quantity: 10 The number of family skills training sessions administered: 10 sessions Family Skills Training Session Mode: Online The mode of administration of family skills training sessions: online |
実験的Session 10, On-Line, Communication and No Cohesion Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering communication but no cohesion | Family Skills Training Content: Communication The content of family skills training sessions administered focused on communication and conflict resolution : communication and conflict resolution Family Skills Training Session Quantity: 10 The number of family skills training sessions administered: 10 sessions Family Skills Training Session Mode: Online The mode of administration of family skills training sessions: online Family Skills Training Content: No Cohesion The content of family skills training sessions administered focused on cohesion: no cohesion |
実験的Session 10, On-Line, Cohesion and No Communication Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering cohesion but no communication | Family Skills Training Content: Cohesion The content of family skills training sessions administered focused on cohesion: cohesion or no cohesion Family Skills Training Session Quantity: 10 The number of family skills training sessions administered: 10 sessions Family Skills Training Session Mode: Online The mode of administration of family skills training sessions: online Family Skills Training Content: No Communication The content of family skills training sessions administered focused on communication and conflict resolution : no communication and conflict resolution |
実験的Session 10, On-Line, No Communication and No Cohesion Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering no communication and no cohesion | Family Skills Training Session Quantity: 10 The number of family skills training sessions administered: 10 sessions Family Skills Training Session Mode: Online The mode of administration of family skills training sessions: online Family Skills Training Content: No Communication The content of family skills training sessions administered focused on communication and conflict resolution : no communication and conflict resolution Family Skills Training Content: No Cohesion The content of family skills training sessions administered focused on cohesion: no cohesion |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in Body weight | Body weight (kg) expressed as a continuous variable will be collected on a digital scale. | baseline and 6 months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Mean Change in Blood Pressure | Both systolic and diastolic blood Pressure measured after 5 minutes of rest and taken in the same position throughout the study. | baseline and 6 months |
Change in skin carotenoids | To assess fruit and vegetable intake, skin carotenoids will be measured using a reflection spectroscopy device ("Veggie Meter") The Veggie Meter uses reflection spectroscopy and a light-emitting diode (LED) light to measure the skin's carotenoids on a scale of 0 to 800. Higher scores indicate more carotenoids, which usually means the person has eaten more fruits and vegetables. | baseline and 6 months |
Change in physical activity steps | To assess physical activity, the number of daily steps will be captured using a Fitbit wearable fitness tracker | baseline and 6 months |
Change in glycosylated hemoglobin (A1c) | Changes in A1c will be measured using a, Point of Contact A1c -Siemens Diabetes 5075 A1C Analyzer | baseline and 6 months |
Current Subjective Social Status | Assesses a person's perceived rank relative to others in their group. The MacArthur Scale of Subjective Social Status (MacArthur SSS Scale) is a single-item measure that assesses a person's perceived rank relative to others in their group. Respondents view a drawing of a ladder with 10 rungs, and either read or hear that the ladder represents where people stand in society. Respondents further read or hear: "At the top of the ladder are the people who are the best off, those who have the most money, most education, and best jobs. At the bottom are the people who are the worst off, those who have the least money, least education, worst jobs, or no job. To score this measure, researchers simply note the number of the rung (1-10) on which the respondent placed their "X." | baseline |
Change in Quality of Life | 12-Item Short Form Survey (SF-12) assessing the impact of health on an individual's everyday life. The 12-Item Short Form Survey (SF-12) is scored by calculating two main scores: a Physical Component Summary (PCS) and a Mental Component Summary (MCS), both ranging from 0 to 100, with higher scores indicating better physical and mental health respectively | baseline and 6 months |
Change in Depression | Patient Health Questionnaire -8 (PHQ-8). To score the Patient Health Questionnaire-8 (PHQ-8), add up the scores from each of the eight items, with each item rated on a scale from 0 ("not at all") to 3 ("nearly every day") - resulting in a total score ranging from 0 to 24; higher scores indicate greater depression severity; generally, a score of 10 or higher is considered clinically significant for major depression, while scores between 5-9 are considered mild depression and 10-14 moderate depression. | baseline and 6 months |
Change in Perceived stress | Measured using Perceived Stress Scale 4 (PSS-4). On the Perceived Stress Scale 4 (PSS-4), each question is scored on a 0-4 scale, with higher scores indicating greater perceived stress, and the total score is calculated by adding up all four items; the possible score range for the PSS-4 is therefore 0-16, with higher scores signifying higher levels of stress. | baseline and 6 months |
Change for social support for exercise | The exercise participation subscale of the Social Support and Exercise Survey (10 items) measures social support specific to exercise behaviors. The subscale assesses the level of support for exercise from partners. Subscale example items include "Exercised with me" and "Criticized or made fun of me for exercising." Total scores range from 5 to 50, with higher scores indicating more social support for exercise participation behaviors. | baseline and 6 months |
Change in Self-Efficacy of Eating Behaviors | Measured by survey responses to the Weight Efficacy Lifestyle Questionnaire Short Form (WEL-SF).Scale goes from 0 (not at all confident) to 10 (very confident). Higher scores mean better self efficacy. | baseline and 6 months |
Change in Self-Efficacy of Physical Activity | The confidence subscale of the Patient-centered Assessment and Counseling for Exercise Adult Diet and Physical Activity Measure (6 items; ) measures confidence in participating in regular exercise or physical activity in different situations (e.g., "How confident are you that you would participate in regular exercise or physical activity: When I am tired?"). Items rated on a scale from 1 ("not at all confident") to 6 ("extremely confident"). Higher scores show higher self-efficacy. | baseline and 6 months |
Changes in self-regulation | Treatment Self-Regulation Questionnaire. To score the Treatment Self-Regulation Questionnaire (TSRQ), each item is typically rated on a 7-point Likert scale, where 1 represents "Not at all true" and 7 represents "Very true," with higher scores indicating a greater degree of autonomous motivation for engaging in the targeted health behavior; | baseline and 6 months |
Changes in nutrition self-efficacy | Nutrition Self-efficacy scale (5 items). To score a 5-item Nutrition Self-Efficacy scale, typically each item is rated on a Likert scale (usually 1-5, with 1 being "not at all confident" and 5 being "very confident"), and then the scores from all five items are added together to produce a total score, with higher scores indicating greater perceived self-efficacy in managing nutrition choices; the total score range would be between 5 (lowest self-efficacy) and 25 (highest self-efficacy) | baseline and 6 months |
Physical Activity Readiness | PHYSICAL ACTIVITY READINESS QUESTIONNAIRE (PAR-Q) \& You. The Physical Activity Readiness Questionnaire (PAR-Q) is a seven-question screening tool that helps determine if a person is healthy enough to exercise. If you answer "yes" to one or more questions, you should consult a physician before starting an exercise program | baseline |
Change in Family Emotional Involvement | The family emotional involvement (7 items) of the Family Emotional Involvement and Criticism Scale rate items on a 5-point Likert scale, as above. | baseline and 6 months |
Change in Family Perceived Criticism | The perceived criticism (7 items) subscales of the Family Emotional Involvement and Criticism Scale rate items like on a 5-point Likert scale, as above. | baseline and 6 months |
Change in Family Collaborative problem solving | The Family Problem-Solving Communication Index (10 items) was used to measure the specific communication style that families use to manage and solve problems and conflicts in various types of stressful situations. Consisting of 2 subscales, affirmatory communication and incendiary communication, the response options were "false," "mostly false," "mostly true," and "true." | baseline and 6 months |
Change in Family Cohesion | The cohesion subscale (10 items) of the Family Adaptability and Cohesion Evaluation Scale III measures the emotional bonding family members have with one another. Items like "Family members ask each other for help" rated on a 5-point Likert scale from "almost never" to "almost always." | baseline and 6 months |
Personal Network Survey | Social Network Analysis using Network Canvas software | baseline |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- self-identified as Black or African American (Index participant)
- BMI equal to greater than 30 kg/m^2 (Index); BMI equal to greater than 27.5 kg/m^2 (family partner)
- have a partner/family member willing to enroll in the study and must share a mutual goal of achieving weight loss
- English speaking
- ages 18-75
- any gender
- have access to and be able to use a smartphone, tablet, or computer that has web-access (this is required for data collection and some program components being tested)
- participation in an intensive weight loss program (more than 12 visits) in the prior 6 months
- type 1 diabetes
- significant psychiatric illness, defined as depression or other major psychiatric illness not considered reasonably managed by counseling, medication, or both
- had bariatric surgery (surgery for weight loss) in the last 2 years or considering bariatric surgery in the next 6 months
- using or planning to start medications intentionally for weight loss
- are pregnant or planning to get pregnant in the next 6 months
- are breastfeeding and less than 2 months postpartum
- alcohol or substance abuse, defined as alcohol or substance use that interferes with work activities and/or has had a major negative impact on family/social function, the latter defined as more than 2 episodes per month.
- malignancy other than non-melanoma skin cancer, unless considered cured > 5 years ago. Exceptions include 1) men with localized prostate cancer (treated with usual modalities or managed with "active surveillance"), and 2) postmenopausal women receiving adjuvant endocrine therapy (e.g., aromatase inhibitor) for non-metastatic, hormone receptor-positive breast cancer
- self-report of advanced kidney disease (estimated glomerular filtration rate (GFR) < 30 mL/min)
ノースカロライナ大学チャペルヒル校245 件のアクティブな治験を探索アメリカ国立心肺血液研究所758 件のアクティブな治験を探索試験中央連絡先
連絡先: Carmen Samuel-Hodge, 919-966-0360, [email protected]
1 1カ国の場所
North Carolina
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, United States
募集中