An interventional study of Together, Eating and Activity, Matter Plus (TEAM+) Online and Together, Eating and Activity, Matter Plus (TEAM+) In-Person in Body Weight, Body Weight Changes and Obesity, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-06.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
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.
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).
1,815 studies on the registry are indexed under Weight Loss; 294 are open to participants now.
This study's enrollment of 21 is below the median of 80 across 1,561 interventional studies indexed under Weight Loss.
Browse Weight Loss studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Compared within Weight Loss, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Body Weight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The index partner will participate in intervention as a dyad with a family member with an in-person skills training.
Behavioral: Together, Eating and Activity, Matter Plus (TEAM+) In-Person
The index partner will participate in intervention as a dyad with a family member with an online skills training.
Behavioral: Together, Eating and Activity, Matter Plus (TEAM+) Online
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.
Also known as: 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.
Also known as: TEAM +
Change in Body Weight
Body weight (kg) expressed as a continuous variable will be collected on a digital scale.
Time frame: Baseline, 12 weeks
Change in Body Mass Index (BMI)
Body mass index calculated from kg/m\^2.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 12 weeks
| Milestone | In-person Family Skills Training | Online Family Skills Training |
|---|---|---|
| Started | 11 | 10 |
| Index partners (including family members enrolled as index partners) | 11 | 8 |
| Family members (non-index partners) | 0 | 2 |
| Completed | 11 | 8 |
| Not completed | 0 | 2 |
Body weight (kg) expressed as a continuous variable will be collected on a digital scale.
| kg | In-person Family Skills Training | Online Family Skills Training |
|---|---|---|
| Change in Body Weight | -0.91 ± 4.83 | -2.92 ± 4.04 |
Body mass index calculated from kg/m\^2.
| kg/m^2 | In-person Family Skills Training | Online Family Skills Training |
|---|---|---|
| Change in Body Mass Index (BMI) | -0.27 ± 2.05 | -0.77 ± 1.33 |
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.
| score on a scale | In-person Family Skills Training | Online Family Skills Training |
|---|---|---|
| Change in Self-Regulation of Eating Behaviors | 7.2 ± 11.21 | 9.29 ± 11.28 |
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.
| units on a scale | In-person Family Skills Training | Online Family Skills Training |
|---|---|---|
| Change in Self-Efficacy of Eating Behaviors | 13.63 ± 18.02 | 9.43 ± 27.40 |
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.
| score on a scale | In-person Family Skills Training | Online Family Skills Training |
|---|---|---|
| Change in Social Support Effectiveness | 2.67 ± 10.07 | -9.0 ± 6.14 |
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.
| score on a scale | In-person Family Skills Training | Online Family Skills Training |
|---|---|---|
| Change in Social Support for Eating | 24.1 ± 14.22 | 30.43 ± 13.80 |
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.
| score on a scale | In-person Family Skills Training | Online Family Skills Training |
|---|---|---|
| Change in Social Support for Exercise | -0.8 ± 11.46 | 1.67 ± 9.53 |
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.
| score on a scale | In-person Family Skills Training | Online Family Skills Training |
|---|---|---|
| Change in Family Communication | 0 ± 1.70 | 1.67 ± 3.86 |
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.
| score on a scale | In-person Family Skills Training | Online Family Skills Training |
|---|---|---|
| Change in Family Cohesion | -0.67 ± 4.37 | 6 ± 7.92 |
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.
| score on a scale | In-person Family Skills Training | Online Family Skills Training |
|---|---|---|
| Change in Family Emotional Involvement | 0.22 ± 2.78 | 2.33 ± 3.09 |
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.
| score on a scale | In-person Family Skills Training | Online Family Skills Training |
|---|---|---|
| Change in Family Perceived Criticism | -1.67 ± 2.98 | -1.67 ± 4.11 |
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.
| score on a scale | In-person Family Skills Training | Online Family Skills Training |
|---|---|---|
| Change in Family Collaborative Problem Solving | -0.11 ± 3.03 | 0.67 ± 2.23 |
Collected over From the time of signing informed consent through study completion, a total of up to 3 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| In-person Family Skills Training | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Online Family Skills Training | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
This study utilized a dyadic design, wherein each Index Participant (IP) was invited to enroll alongside a Family Member(FM). In certain cases, FM also elected to enroll as IP (together with an IP). The reported enrollment figures reflect all individuals who were formally enrolled as IP. No data were collected for FM who did not enroll as IP; therefore, these individuals are not represented in the reported data.
| Age, Continuous(years) | In-person Family Skills Training | Online Family Skills Training | Total |
|---|---|---|---|
| Mean | 44.27 ± 13.76 | 54.13 ± 13.15 | 49.58 ± 14.05 |
| Sex: Female, Male(Participants) | In-person Family Skills Training | Online Family Skills Training | Total |
|---|---|---|---|
| Female | 6 | 6 | 12 |
| Male | 5 | 2 | 7 |
| Ethnicity (NIH/OMB)(Participants) | In-person Family Skills Training | Online Family Skills Training | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 11 | 8 | 19 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | In-person Family Skills Training | Online Family Skills Training | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 11 | 8 | 19 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | In-person Family Skills Training | Online Family Skills Training | Total |
|---|---|---|---|
| United States | 11 | 8 | 19 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: beginning 9 and continuing for 36 months following publication
Access criteria: Investigator has approved from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Ran from Feb 2024 to primary completion in Aug 2024, 6 months.
Results were first posted in Nov 2025, 1 year 2 months after primary completion.
Of 670 non-industry interventional studies with no phase under Weight Loss, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's 6 months is below that.
Counting every sponsor, half of 729 studies reached it within 24 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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