Behavior Change, Diabetes Mellitus, Obesity and Overweight, Weight Loss
Conditions
Keywords
weight loss program, African American or Black families, nutrition and physical activity behavior change
Brief summary
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
Detailed description
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.
Interventions
BEHAVIORALFamily Skills Training Session Quantity: 5
The number of family skills training sessions administered: 5 sessions
BEHAVIORALFamily Skills Training Session Mode: In-person
The mode of administration of family skills training sessions: in person or online
BEHAVIORALFamily Skills Training Content: Communication
The content of family skills training sessions administered focused on communication and conflict resolution : communication and conflict resolution
BEHAVIORALFamily Skills Training Content: Cohesion
The content of family skills training sessions administered focused on cohesion: cohesion or no cohesion
BEHAVIORALFamily Skills Training Session Quantity: 10
The number of family skills training sessions administered: 10 sessions
BEHAVIORALFamily Skills Training Session Mode: Online
The mode of administration of family skills training sessions: online
BEHAVIORALFamily Skills Training Content: No Communication
The content of family skills training sessions administered focused on communication and conflict resolution : no communication and conflict resolution
BEHAVIORALFamily Skills Training Content: No Cohesion
The content of family skills training sessions administered focused on cohesion: no cohesion
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body weight | baseline and 6 months | Body weight (kg) expressed as a continuous variable will be collected on a digital scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Blood Pressure | baseline and 6 months | Both systolic and diastolic blood Pressure measured after 5 minutes of rest and taken in the same position throughout the study. |
| Change in skin carotenoids | baseline and 6 months | 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. |
| Change in physical activity steps | baseline and 6 months | To assess physical activity, the number of daily steps will be captured using a Fitbit wearable fitness tracker |
| Change in glycosylated hemoglobin (A1c) | baseline and 6 months | Changes in A1c will be measured using a, Point of Contact A1c -Siemens Diabetes 5075 A1C Analyzer |
| Current Subjective Social Status | baseline | 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. |
| Change in Quality of Life | baseline and 6 months | 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 |
| Change in Depression | baseline and 6 months | 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. |
| Change in Perceived stress | baseline and 6 months | 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. |
| Change for social support for exercise | baseline and 6 months | 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. |
| Change in Self-Efficacy of Physical Activity | baseline and 6 months | 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. |
| Changes in self-regulation | baseline and 6 months | 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; |
| Changes in nutrition self-efficacy | baseline and 6 months | 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) |
| Physical Activity Readiness | baseline | 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 |
| Change in Family Emotional Involvement | baseline and 6 months | The family emotional involvement (7 items) of the Family Emotional Involvement and Criticism Scale rate items on a 5-point Likert scale, as above. |
| Change in Family Perceived Criticism | baseline and 6 months | 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. |
| Change in Family Collaborative problem solving | baseline and 6 months | 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. |
| Change in Family Cohesion | baseline and 6 months | 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. |
| Personal Network Survey | baseline | Social Network Analysis using Network Canvas software |
| Change in Self-Efficacy of Eating Behaviors | baseline and 6 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change for social support for eating | baseline and 6 months | 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. |
Countries
United States
Contacts
Primary ContactCarmen Samuel-Hodge
Outcome results
None listed