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| ID | Type | Description | Link |
|---|---|---|---|
| R61HL169357 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Session 5, In-Person, Communication and Cohesion | Experimental | Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering communication and cohesion |
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| Session 5, In-Person, Communication and No Cohesion | Experimental | Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering communication but no cohesion |
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| Session 5, In-Person, Cohesion and No Communication | Experimental | Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering cohesion but no communication |
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| Session 5, In-Person, No Communication and No Cohesion | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family Skills Training Session Quantity: 5 | Behavioral | The number of family skills training sessions administered: 5 sessions |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Body weight | Body weight (kg) expressed as a continuous variable will be collected on a digital scale. | baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change for social support for eating | The Social Support and Eating Habits Survey (10 items) measures social support specific to healthy eating. Subscales assess encouragement for eating behaviors from partners (e.g., "Encouraged me not to eat 'unhealthy food' when I am tempted") and discouragement for eating behaviors from partners (e.g., "Brought home foods I am trying not to eat"). The items are rated on a scale of "none" to "very often." Total scores range from 5 to 50, with higher scores indicating more social support for eating behaviors. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carmen Samuel-Hodge | Contact | 919-966-0360 | cdsamuel@email.unc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Carmen Samuel-Hodge, PhD, MS, RD, LDN | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
We plan to preserve all the study data and to make it available to other researchers as appropriate, except that audio recordings of semi-structured interviews will NOT be made available, but the transcripts of these interviews will be made available. We do not plan to transcribe the fidelity audio recordings, so these data will not be made available. Our rationale for not sharing the audio recorded data is to minimize the risk of loss of confidentiality. All stored data are de-identified. Data will be made available no later than the time of an associated publication.
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Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina.
When data sharing is permitted, a Data Use Agreement (DUA) specifying the uses of such data to be shared must be in place before any data is shared. Requests can be submitted to the Industry Contracting for processing. The Principal Investigator must confirm that the DUA has been fully executed and IRB, IEC, or REB approval has been granted before sharing data.
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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
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| Session 5, On-Line, Communication and Cohesion | Experimental | Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering communication and cohesion |
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| Session 5, On-Line, Communication and No Cohesion | Experimental | Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering communication but no cohesion |
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| Session 5, On-Line, Cohesion and No Communication | Experimental | Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering cohesion but no communication |
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| Session 5, On-Line, No Communication and No Cohesion | Experimental | 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 |
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| Session 10, In-Person, Communication and Cohesion | Experimental | Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering communication and cohesion |
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| Session 10, In-Person, Communication and No Cohesion | Experimental | Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering communication but no cohesion |
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| Session 10, In-Person, Cohesion and No Communication | Experimental | 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 |
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| Session 10, In-Person, No Communication and No Cohesion | Experimental | 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 |
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| Session 10, On-Line, Communication and Cohesion | Experimental | Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering communication and cohesion |
|
| Session 10, On-Line, Communication and No Cohesion | Experimental | Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering communication but no cohesion |
|
| Session 10, On-Line, Cohesion and No Communication | Experimental | Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering cohesion but no communication |
|
| Session 10, On-Line, No Communication and No Cohesion | Experimental | 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 |
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| Family Skills Training Session Mode: In-person | Behavioral | The mode of administration of family skills training sessions: in person or online |
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| Family Skills Training Content: Communication | Behavioral | The content of family skills training sessions administered focused on communication and conflict resolution : communication and conflict resolution |
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| Family Skills Training Content: Cohesion | Behavioral | The content of family skills training sessions administered focused on cohesion: cohesion or no cohesion |
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| Family Skills Training Session Quantity: 10 | Behavioral | The number of family skills training sessions administered: 10 sessions |
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| Family Skills Training Session Mode: Online | Behavioral | The mode of administration of family skills training sessions: online |
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| Family Skills Training Content: No Communication | Behavioral | The content of family skills training sessions administered focused on communication and conflict resolution : no communication and conflict resolution |
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| Family Skills Training Content: No Cohesion | Behavioral | The content of family skills training sessions administered focused on cohesion: no cohesion |
|
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 |
| baseline and 6 months |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D003920 | Diabetes Mellitus |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001836 | Body Weight Changes |
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