Body WeightTEAM+NCT05981508
Online Family Dyadic Skills Training for Black Adults in Behavioral Weight Loss Program
A study testing Together, Eating and Activity, Matter Plus (TEAM+) Online and Together, Eating and Activity, Matter Plus (TEAM+) In-Person in people with Body Weight and Body Weight Changes, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight, Body Weight Changes, Obesity
- What is being tested?
- Together, Eating and Activity, Matter Plus (TEAM+) Online and Together, Eating and Activity, Matter Plus (TEAM+) In-Person
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2024to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- not interested in losing weight
- have any conditions affecting weight
- currently receiving cancer treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Health Promotion and Disease Prevention
Chapel Hill, North Carolina, 27499
About this study
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.
Read the 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).
- Conditions
- Body Weight, Body Weight Changes, Obesity, Overweight and Obesity, Overweight, Behavior, Eating
- Being tested
- Together, Eating and Activity, Matter Plus (TEAM+) Online, Together, Eating and Activity, Matter Plus (TEAM+) In-Person
- Medical subject headings
- Body Weight, Body Weight Changes, Obesity, Overweight, Feeding Behavior, Sedentary Behavior, Chronic Disease, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Together, Eating and Activity, Matter Plus (TEAM+) OnlineBehavioural
Also called TEAM +
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.
Together, Eating and Activity, Matter Plus (TEAM+) In-PersonBehavioural
Also called TEAM +
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.
| Study group | Role | What they receive |
|---|---|---|
| In-person Family Skills Training | Active comparator | The index partner will participate in intervention as a dyad with a family member with an in-person skills training. Receives: Behavioral: Together, Eating and Activity, Matter Plus (TEAM+) In-Person |
| Online Family Skills Training | Experimental | The index partner will participate in intervention as a dyad with a family member with an online skills training. Receives: Behavioral: Together, Eating and Activity, Matter Plus (TEAM+) Online |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Body weight (kg) expressed as a continuous variable will be collected on a digital scale.
Measured: Baseline, 12 weeks
Secondary outcomes (11)
Change in Body Mass Index (BMI)
Body mass index calculated from kg/m^2.
Measured: Baseline,12 weeks
Change in Self-Regulation of Eating Behaviors
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.
Measured: Baseline,12 weeks
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. 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.
Measured: Baseline,12 weeks
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. All responses are numerically transformed. Total scores range from 0 to 80, with higher scores indicating more effective support.
Measured: Baseline,12 weeks
Change in Social Support for Eating
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.
Measured: Baseline,12 weeks
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 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.
Measured: Baseline,12 weeks
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." . 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.
Measured: Baseline, 12 weeks
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." The score has a range of 10 to 50.
Measured: Baseline, 12 weeks
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. The scale has a range of 7 to 35. Higher scores on the emotional involvement subscale indicate higher levels of perceived emotional involvement.
Measured: Baseline, 12 weeks
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. The scale has a range of 7 to 35. Higher scores on the perceived criticism scale indicate higher levels of perceived emotional involvement.
Measured: Baseline, 12 weeks
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. 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.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start5 Feb 2024
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Body WeightStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Splendor-NC
- Responsible party
- Sponsor
- Investigators
- Candice Alick, PhD, MS, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981508
- Sponsor's protocol ID
- 23-1598
- Other IDs
- 5U24DK132715-03
- Acronym
- TEAM+
- Status last verified
- Jul 2023
- First submitted
- 31 Jul 2023
- Last updated
- 6 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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 UNC.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study 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+)
- ClinicalTrials.gov ID
- NCT05981508
- Acronym / sponsor ID
- TEAM+ / 23-1598
- Conditions
- Body Weight, Body Weight Changes, Obesity, Overweight and Obesity, Overweight, Behavior, Eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Splendor-NC
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 8 Aug 2023 (actual)
- Results
- Posted 6 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-person Family Skills Training | Active comparator | Behavioral: Together, Eating and Activity, Matter Plus (TEAM+) In-PersonThe index partner will participate in intervention as a dyad with a family member with an in-person skills training. |
| Online Family Skills Training | Experimental | Behavioral: Together, Eating and Activity, Matter Plus (TEAM+) OnlineThe index partner will participate in intervention as a dyad with a family member with an online skills training. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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,
Key exclusion criteria (3 listed)
- not interested in losing weight
- have any conditions affecting weight
- currently receiving cancer treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Together, Eating and Activity, Matter Plus (TEAM+) OnlineAlso: TEAM +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. | Behavioural | Online Family Skills Training |
| Together, Eating and Activity, Matter Plus (TEAM+) In-PersonAlso: TEAM +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. | Behavioural | In-person Family Skills Training |
Primary outcome
Change in Body Weight
Time frame: Baseline, 12 weeks
Body weight (kg) expressed as a continuous variable will be collected on a digital scale.
11 secondary outcomes
Change in Body Mass Index (BMI)
Time frame: Baseline,12 weeks
Change in Self-Regulation of Eating Behaviors
Time frame: Baseline,12 weeks
Change in Self-Efficacy of Eating Behaviors
Time frame: Baseline,12 weeks
Change in Social Support Effectiveness
Time frame: Baseline,12 weeks
Change in Social Support for Eating
Time frame: Baseline,12 weeks
Change in Social Support for Exercise
Time frame: Baseline,12 weeks
Change in Family Communication
Time frame: Baseline, 12 weeks
Change in Family Cohesion
Time frame: Baseline, 12 weeks
Change in Family Emotional Involvement
Time frame: Baseline, 12 weeks
Change in Family Perceived Criticism
Time frame: Baseline, 12 weeks
Change in Family Collaborative Problem Solving
Time frame: Baseline, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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 UNC.
Related trials for Body Weight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Candice Alick, PhD, MS principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Together, Eating and Activity, Matter Plus (TEAM+) Online and Together, Eating and Activity, Matter Plus (TEAM+) In-Person in people with Body Weight and Body Weight Changes, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.