- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05981508
Online Family Dyadic Skills Training for Black Adults in Behavioral Weight Loss Program (TEAM+)
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 Overview
Status
Conditions
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27499
- Center for Health Promotion and Disease Prevention
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: In-person Family Skills Training
The index partner will participate in intervention as a dyad with a family member with an in-person skills training.
|
TEAM+ is a 3-month, family enhanced behavioral weight loss (BWL) intervention designed for Black adults consisting of in-person family dyadic skills training and core behavioral weight loss sessions.
Other Names:
|
|
Experimental: Online Family Skills Training
The index partner will participate in intervention as a dyad with a family member with an online skills training.
|
TEAM+ is a 3-month, family enhanced behavioral weight loss (BWL) intervention designed for Black adults consisting of an online family dyadic skills training and in-person core behavioral weight loss sessions.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body Weight
Time Frame: Baseline, 12 weeks
|
Body weight (kg) expressed as a continuous variable will be collected on a digital scale.
|
Baseline, 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body Mass Index (BMI)
Time Frame: Baseline,12 weeks
|
Body mass index calculated from kg/m^2.
|
Baseline,12 weeks
|
|
Change in Self-Regulation of Eating Behaviors
Time Frame: Baseline,12 weeks
|
The Eating Behavior Inventory (EBI) 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. Items are scored such that higher scores indicate eating patterns that are considered more "appropriate" or facilitative of weight control.
|
Baseline,12 weeks
|
|
Change in Self-Efficacy of Eating Behaviors
Time Frame: Baseline,12 weeks
|
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.
The total score on the WEL-SF ranges from 0 to 80, with higher scores indicating greater self-efficacy in controlling eating behaviors.
There are 8 items.
This information presented here represents change scores from baseline to post intervention.
|
Baseline,12 weeks
|
|
Change in Social Support Effectiveness
Time Frame: Baseline,12 weeks
|
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.
All responses are numerically transformed.
Total scores range from 0 to 80, with higher scores indicating more effective support.
|
Baseline,12 weeks
|
|
Change in Social Support for Eating
Time Frame: Baseline,12 weeks
|
The Social Support and Eating Habits Survey (10 items) measures social support specific to healthy eating.
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
|
|
Change in Social Support for Exercise
Time Frame: Baseline,12 weeks
|
The exercise participation subscale of the Social Support and Exercise Survey (10 items) measures social support specific to exercise behaviors assessing 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
|
|
Change in Family Communication
Time Frame: Baseline, 12 weeks
|
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." .
Uses a 4-point Likert scale for responses, ranging from "strongly disagree" to "strongly agree", subscale 1-4.
Total score range 6-24.
Higher scores represent unhealthy communication.
Change score from baseline to post intervention presented here.
|
Baseline, 12 weeks
|
|
Change in Family Cohesion
Time Frame: Baseline, 12 weeks
|
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."
The score has a range of 10 to 50.
|
Baseline, 12 weeks
|
|
Change in Family Emotional Involvement
Time Frame: Baseline, 12 weeks
|
The family emotional involvement (7 items) of the Family Emotional Involvement and Criticism Scale rate items on a 5-point Likert scale.
The scale has a range of 7 to 35.
Higher scores on the emotional involvement subscale indicate higher levels of perceived emotional involvement.
|
Baseline, 12 weeks
|
|
Change in Family Perceived Criticism
Time Frame: Baseline, 12 weeks
|
The perceived criticism (7 items) subscales of the Family Emotional Involvement and Criticism Scale rate items like on a 5-point Likert scale.
The scale has a range of 7 to 35.
Higher scores on the perceived criticism scale indicate higher levels of perceived emotional involvement.
|
Baseline, 12 weeks
|
|
Change in Family Collaborative Problem Solving
Time Frame: Baseline, 12 weeks
|
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.
The 2 subscales are combined to report a total score for affirmatory communication and incendiary communication combined, the response options were "false," "mostly false," "mostly true," and "true."
Scores range from 10 to 50 and a higher/lower score reflects a worse problem solving skills.
|
Baseline, 12 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Candice Alick, PhD, MS, University of North Carolina, Chapel Hill
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nutrition Disorders
- Disease Attributes
- Overnutrition
- Pathological Conditions, Signs and Symptoms
- Behavior
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Behavior, Animal
- Overweight
- Obesity
- Weight Loss
- Body Weight
- Body Weight Changes
- Chronic Disease
- Sedentary Behavior
- Feeding Behavior
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Diet, Food, and Nutrition
- Physiological Phenomena
- Nutritional Physiological Phenomena
- Digestive System Physiological Phenomena
- Digestive System and Oral Physiological Phenomena
- Exercise
- Eating
Other Study ID Numbers
- 23-1598
- 5U24DK132715-03 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | Obesity and Obesity-related Medical ConditionsUnited States
-
Central Hospital, Nancy, FranceNot yet recruiting
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsCompletedOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | GLP-1 | Obesity and Obesity-related Medical Conditions | Ablation TechniquesUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
Clinical Trials on Together, Eating and Activity, Matter Plus (TEAM+) In-Person
-
University of Wisconsin, MadisonNational Institute on Drug Abuse (NIDA)RecruitingChronic Medical Conditions | Substance Use Disorder (SUD) | Prisoners | Substance Use History | Psychiatric ConditionUnited States
-
Medco Health Solutions, Inc.Coventry Health Care, Inc.TerminatedHeart Failure | Cardiovascular Disease | Diabetes | Chronic Obstructive Pulmonary Disease | OsteoporosisUnited States
-
University of Colorado, DenverJohns Hopkins University; University of Alabama at Birmingham; Kenya Medical...CompletedHuman Immunodeficiency VirusKenya
-
University of MinnesotaNational Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Diseases | Cardiovascular Diseases | ObesityUnited States
-
Hunan Normal UniversityCompletedParental Stress | Autism Spectrum Disorder (ASD | Sleep Disturbances in ChildrenChina
-
Kyungdong UniversityCompletedFrail ElderlyKorea, Republic of
-
Penn State UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
San Diego State UniversityCenters for Disease Control and PreventionCompletedChildhood ObesityUnited States
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of Sheffield; National Institute for Health Research: CLAHRC YH; The... and other collaboratorsCompletedChronic Obstructive Pulmonary Disease (COPD)United Kingdom