Obesity Clinical Trial
— TEAM+Official title:
Feasibility of Conducting an Online Family Dyadic/Couple Skills Training for Black Adults Enrolled in a Behavioral Weight Loss Intervention - Together, Eating and Activity, Matter+ (TEAM+)
The purpose of this research study is to test the feasibility and acceptability of an interactive counselor -led online family skills training as part of a behavioral weight loss program for Black Adults.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | August 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - self-identify as a Black or African American, - are between 18-75 years old - have a family member willing to attend study session with you - have Internet access - reside in the Raleigh/Durham/Chapel Hill area, Exclusion Criteria: - not interested in losing weight - have any conditions affecting weight - currently receiving cancer treatment |
Country | Name | City | State |
---|---|---|---|
United States | Center for Health Promotion and Disease Prevention | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Splendor-NC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Body Weight | Body weight (kg) expressed as a continuous variable will be collected on a digital scale. | Baseline, 12 weeks | |
Secondary | Change in Waist Circumference | Measured in a standing position, at midpoint between the lower border of the last rib and the upper border of the iliac crest on the horizontal place, using an inextensible Gulick measuring tape graduated in cm. | Baseline,12 weeks | |
Secondary | Change in Body Mass Index (BMI) | Body mass index calculated from kg/m^2. | Baseline,12 weeks | |
Secondary | 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,12 weeks | |
Secondary | Change in Caloric Intake | To assess behavioral change the Automated-Self Administered Recall System (ASA24) will be used to determine daily kcal. | Baseline,12 weeks | |
Secondary | Change in Physical Activity | The Paffenbarger Physical Activity Questionnaire (PPAQ) is an eight-item questionnaire that is scored by measuring minutes per week of Moderate to Vigorous Physical Activity (MVPA) by adding block per day and and physical activity of at least moderate level; not measured on a scale. | Baseline,12 weeks | |
Secondary | Change in Self-Regulation of Eating Behaviors | The Eating Behavior Inventory (20 items) measures the adoption of eating behaviors associated with weight loss (e.g., monitoring quantity eaten, frequency of weighing, shopping from a list) to measure self-regulation behaviors. Items are rated on a 5-point frequency scale from "never or hardly ever" to "always or almost always." Scores range from 26 to 130. | Baseline,12 weeks | |
Secondary | 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,12 weeks | |
Secondary | 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,12 weeks | |
Secondary | Change in Social Support Effectiveness | Social Support Effectiveness Survey (25 items) measures partner social support effectiveness. The measure includes items assessing the quantity and quality (e.g., "To what extent did you wish this person's advice or information had been different somehow-for instance, a different type of help, or offered in a different way or at a different time?") on a rating scale ranging from "not at all" to "extremely" for 3 types of support (e.g., emotional, informational, and instrumental). The measure also assesses negative byproducts of support provided (e.g., feelings of guilt or indebtedness) using Yes/No options. Total scores range from 0 to 80, with higher scores indicating more effective support. | Baseline,12 weeks | |
Secondary | Change in 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. | Baseline,12 weeks | |
Secondary | Change in 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,12 weeks | |
Secondary | Change in Family Communication | Family communication is assessed with the communication subscale of the McMaster Family Assessment Device (6 items). Communication is defined as the exchange of information among family members. Items focused on whether verbal messages were clear and direct for the intended recipient. Responses ranged from "strongly agree" to "strongly disagree." Higher scores represent unhealthy communication. | Baseline, 12 weeks | |
Secondary | 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, 12 weeks | |
Secondary | 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, 12 weeks | |
Secondary | 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, 12 weeks | |
Secondary | 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, 12 weeks |
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