Clinical trial NCT05981508: Online Family Dyadic Skills Training for Black Adults in Behavioral Weight Loss Program
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+)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight
Body Weight Changes
Obesity
Overweight and Obesity
Overweight
Behavior, Eating
Physical Inactivity
Chronic Disease
Weight Loss
Weight Reduction
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Splendor-NC
First posted: 2023-08-08
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Nearly half (49.9%) of Black adults in the United States live with obesity. Black adults are underrepresented in standard behavioral weight loss (BWL) interventions and experience sub-optimal weight loss outcomes when included in such programs. Cultural adaptations to BWL interventions that recognize the family behavioral context and address the cultural value of family among Black populations are needed to improve weight loss outcomes. Prior research, including our randomized controlled pilot, Together, Eating and Activity, Matter Plus (TEAM+), have incorporated family skills training to enhance family involvement, targeting cohesion and communication, in addition to core weight loss curriculum. However, family inclusion in weight loss interventions can result in additional barriers to retention and adherence.

Technology has become an attractive delivery format to increase reach to at-risk populations, as a well-designed online program can address issues of timely access and geographical location (or distance from program sites), which are linked to low retention of Black participants. However, technology uptake among Blacks populations still lags due to mistrust, skepticism, concerns about confidentiality, privacy, and remote interaction with staff. Increases in acceptance and utilization of telemedicine and mobile-health were reported during the COVID-19 pandemic. Considering the time and location burden already associated with behavioral weight loss sessions, it is important to identify strategies to increase access that are both feasible and acceptable in the target population. Currently the feasibility and acceptability of an online family dyadic skills training is unknown among Black adults.

TEAM+ is an in-person 3-month family enhanced BWL intervention designed for Black adults consisting of a family dyadic skills training and core behavioral weight loss sessions. For this proposed pilot study, 20 black adults interested in weight loss will be recruited with a family member committed to attending both the skills training and core sessions. Participants must 1) be ≥18 years of age, 2) self-identify as Black/African American, 3) reside in the Raleigh/Durham/Chapel Hill area, and 4) have internet access. The core sessions will be delivered in person. To test the feasibility and acceptability of an interactive counselor-led online training, the family dyadic skills training will be delivered online using a web-conferencing platform (e.g., Zoom).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Body Weight
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change in Waist Circumference
timeFrame: Baseline,12 weeks
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline,12 weeks
measure: Mean Change in Blood Pressure
timeFrame: Baseline,12 weeks
measure: Change in Caloric Intake
timeFrame: Baseline,12 weeks
measure: Change in Physical Activity
timeFrame: Baseline,12 weeks
measure: Change in Self-Regulation of Eating Behaviors
timeFrame: Baseline,12 weeks
measure: Change in Self-Efficacy of Eating Behaviors
timeFrame: Baseline,12 weeks
measure: Change in Self-Efficacy of Physical Activity
timeFrame: Baseline,12 weeks
measure: Change in Social Support Effectiveness
timeFrame: Baseline,12 weeks
measure: Change in Social Support for Eating
timeFrame: Baseline,12 weeks
measure: Change in Social Support for Exercise
timeFrame: Baseline,12 weeks
measure: Change in Family Communication
timeFrame: Baseline, 12 weeks
measure: Change in Family Cohesion
timeFrame: Baseline, 12 weeks
measure: Change in Family Emotional Involvement
timeFrame: Baseline, 12 weeks
measure: Change in Family Perceived Criticism
timeFrame: Baseline, 12 weeks
measure: Change in Family Collaborative problem solving
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Center for Health Promotion and Disease Prevention
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Candice Alick, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References: