Trial Outcomes & Findings for Online Family Dyadic Skills Training for Black Adults in Behavioral Weight Loss Program (NCT NCT05981508)

NCT ID: NCT05981508

Last Updated: 2025-11-06

Results Overview

Body weight (kg) expressed as a continuous variable will be collected on a digital scale.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

Baseline, 12 weeks

Results posted on

2025-11-06

Participant Flow

This was a dyad based study in which each Index Participant(IP) was invited to enroll with a Family Member(FM). In some cases, FM also chose to enroll as IP as part of the related dyad. The reported data reflect all enrolled IP, including those who were also FM. FM not enrolled as IP were nonetheless represented in the participant flow as FM. No data were collected for FM who did not enroll as IP. As such, these individuals are not represented in any of the reported data.

Participant milestones

Participant milestones
Measure
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. Together, Eating and Activity, Matter Plus (TEAM+) In-Person: 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.
Online Family Skills Training
The index partner will participate in intervention as a dyad with a family member with an online skills training. 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.
Overall Study
STARTED
11
10
Overall Study
Index Partners (Including Family Members Enrolled as Index Partners)
11
8
Overall Study
Family Members (Non-Index Partners)
0
2
Overall Study
COMPLETED
11
8
Overall Study
NOT COMPLETED
0
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Online Family Dyadic Skills Training for Black Adults in Behavioral Weight Loss Program

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
In-person Family Skills Training
n=11 Participants
The index partner participated in intervention as a dyad with a family member with an in-person skills training. Together, Eating and Activity, Matter Plus (TEAM+) In-Person: 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.
Online Family Skills Training
n=8 Participants
The index partner participated in intervention as a dyad with a family member with an online skills training. 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.
Total
n=19 Participants
Total of all reporting groups
Age, Continuous
44.27 years
STANDARD_DEVIATION 13.76 • n=49 Participants
54.13 years
STANDARD_DEVIATION 13.15 • n=50 Participants
49.58 years
STANDARD_DEVIATION 14.05 • n=50 Participants
Sex: Female, Male
Female
6 Participants
n=49 Participants
6 Participants
n=50 Participants
12 Participants
n=50 Participants
Sex: Female, Male
Male
5 Participants
n=49 Participants
2 Participants
n=50 Participants
7 Participants
n=50 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=49 Participants
0 Participants
n=50 Participants
0 Participants
n=50 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
11 Participants
n=49 Participants
8 Participants
n=50 Participants
19 Participants
n=50 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=49 Participants
0 Participants
n=50 Participants
0 Participants
n=50 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=49 Participants
0 Participants
n=50 Participants
0 Participants
n=50 Participants
Race (NIH/OMB)
Asian
0 Participants
n=49 Participants
0 Participants
n=50 Participants
0 Participants
n=50 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=49 Participants
0 Participants
n=50 Participants
0 Participants
n=50 Participants
Race (NIH/OMB)
Black or African American
11 Participants
n=49 Participants
8 Participants
n=50 Participants
19 Participants
n=50 Participants
Race (NIH/OMB)
White
0 Participants
n=49 Participants
0 Participants
n=50 Participants
0 Participants
n=50 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=49 Participants
0 Participants
n=50 Participants
0 Participants
n=50 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=49 Participants
0 Participants
n=50 Participants
0 Participants
n=50 Participants
Region of Enrollment
United States
11 Participants
n=49 Participants
8 Participants
n=50 Participants
19 Participants
n=50 Participants

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Population: Overall Number of Participants Analyzed in this measure includes Index Participants. Family Member who were part of a dyad did not participate in data collection are not included in the reported numbers.

Body weight (kg) expressed as a continuous variable will be collected on a digital scale.

Outcome measures

Outcome measures
Measure
In-person Family Skills Training
n=11 Participants
The index partner participated in intervention as a dyad with a family member with an in-person skills training. Together, Eating and Activity, Matter Plus (TEAM+) In-Person: 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.
Online Family Skills Training
n=8 Participants
The index partner participated in intervention as a dyad with a family member with an online skills training. 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.
Change in Body Weight
-0.91 kg
Standard Deviation 4.83
-2.92 kg
Standard Deviation 4.04

SECONDARY outcome

Timeframe: Baseline,12 weeks

Population: All collected data are reported. Two participants (one from the in-person) could not have their height recorded during the assessment. Overall Number of Participants Analyzed in this measure includes Index Participants. Family Member who were part of a dyad did not participate in data collection are not included in the reported numbers.

Body mass index calculated from kg/m\^2.

Outcome measures

Outcome measures
Measure
In-person Family Skills Training
n=9 Participants
The index partner participated in intervention as a dyad with a family member with an in-person skills training. Together, Eating and Activity, Matter Plus (TEAM+) In-Person: 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.
Online Family Skills Training
n=8 Participants
The index partner participated in intervention as a dyad with a family member with an online skills training. 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.
Change in Body Mass Index (BMI)
-0.27 kg/m^2
Standard Deviation 2.05
-0.77 kg/m^2
Standard Deviation 1.33

SECONDARY outcome

Timeframe: Baseline,12 weeks

Population: All collected data are reported. Two participants (one from each Arm) did not complete the EBI. Overall Number of Participants Analyzed in this measure includes Index Participants. Family Member who were part of a dyad did not participate in data collection are not included in the reported numbers.

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.

Outcome measures

Outcome measures
Measure
In-person Family Skills Training
n=10 Participants
The index partner participated in intervention as a dyad with a family member with an in-person skills training. Together, Eating and Activity, Matter Plus (TEAM+) In-Person: 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.
Online Family Skills Training
n=7 Participants
The index partner participated in intervention as a dyad with a family member with an online skills training. 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.
Change in Self-Regulation of Eating Behaviors
7.2 score on a scale
Standard Deviation 11.21
9.29 score on a scale
Standard Deviation 11.28

SECONDARY outcome

Timeframe: Baseline,12 weeks

Population: All collected data are reported. Three participants (two from the in-person arm and one from the online arm) did not complete the WEL-SF. Overall Number of Participants Analyzed in this measure includes Index Participants. Family Member who were part of a dyad did not participate in data collection are not included in the reported numbers.

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.

Outcome measures

Outcome measures
Measure
In-person Family Skills Training
n=9 Participants
The index partner participated in intervention as a dyad with a family member with an in-person skills training. Together, Eating and Activity, Matter Plus (TEAM+) In-Person: 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.
Online Family Skills Training
n=7 Participants
The index partner participated in intervention as a dyad with a family member with an online skills training. 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.
Change in Self-Efficacy of Eating Behaviors
13.63 units on a scale
Standard Deviation 18.02
9.43 units on a scale
Standard Deviation 27.40

SECONDARY outcome

Timeframe: Baseline,12 weeks

Population: All collected data are reported. Four participants (two from the in-person arm and two from the online arm) did not complete the Social Support Effectiveness Survey. Overall Number of Participants Analyzed in this measure includes Index Participants. Family Member who were part of a dyad did not participate in data collection are not included in the reported numbers.

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.

Outcome measures

Outcome measures
Measure
In-person Family Skills Training
n=9 Participants
The index partner participated in intervention as a dyad with a family member with an in-person skills training. Together, Eating and Activity, Matter Plus (TEAM+) In-Person: 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.
Online Family Skills Training
n=6 Participants
The index partner participated in intervention as a dyad with a family member with an online skills training. 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.
Change in Social Support Effectiveness
2.67 score on a scale
Standard Deviation 10.07
-9.0 score on a scale
Standard Deviation 6.14

SECONDARY outcome

Timeframe: Baseline,12 weeks

Population: All collected data are reported. Two participants (two from the in-person arm and one from the online arm) did not complete the Social Support and Eating Habits Survey. Overall Number of Participants Analyzed in this measure includes Index Participants. Family Member who were part of a dyad did not participate in data collection are not included in the reported numbers.

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.

Outcome measures

Outcome measures
Measure
In-person Family Skills Training
n=10 Participants
The index partner participated in intervention as a dyad with a family member with an in-person skills training. Together, Eating and Activity, Matter Plus (TEAM+) In-Person: 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.
Online Family Skills Training
n=7 Participants
The index partner participated in intervention as a dyad with a family member with an online skills training. 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.
Change in Social Support for Eating
24.1 score on a scale
Standard Deviation 14.22
30.43 score on a scale
Standard Deviation 13.80

SECONDARY outcome

Timeframe: Baseline,12 weeks

Population: All collected data are reported. Three participants (one from the in-person arm and two from the online arm) did not complete the Social Support and Exercise Survey. Overall Number of Participants Analyzed in this measure includes Index Participants. Family Member who were part of a dyad did not participate in data collection are not included in the reported numbers.

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.

Outcome measures

Outcome measures
Measure
In-person Family Skills Training
n=10 Participants
The index partner participated in intervention as a dyad with a family member with an in-person skills training. Together, Eating and Activity, Matter Plus (TEAM+) In-Person: 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.
Online Family Skills Training
n=6 Participants
The index partner participated in intervention as a dyad with a family member with an online skills training. 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.
Change in Social Support for Exercise
-0.8 score on a scale
Standard Deviation 11.46
1.67 score on a scale
Standard Deviation 9.53

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Population: All collected data are reported. Four participants (two from the in-person arm and two from the online arm) did not complete the McMaster Family Assessment Device Communication scale. Overall Number of Participants Analyzed in this measure includes Index Participants. Family Member who were part of a dyad did not participate in data collection are not included in the reported numbers.

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.

Outcome measures

Outcome measures
Measure
In-person Family Skills Training
n=9 Participants
The index partner participated in intervention as a dyad with a family member with an in-person skills training. Together, Eating and Activity, Matter Plus (TEAM+) In-Person: 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.
Online Family Skills Training
n=6 Participants
The index partner participated in intervention as a dyad with a family member with an online skills training. 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.
Change in Family Communication
0 score on a scale
Standard Deviation 1.70
1.67 score on a scale
Standard Deviation 3.86

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Population: All collected data are reported. Four participants (two from the in-person arm and two from the online arm) did not complete the Family Adaptability and Cohesion Evaluation Scale III. Overall Number of Participants Analyzed in this measure includes Index Participants. Family Member who were part of a dyad did not participate in data collection are not included in the reported numbers.

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.

Outcome measures

Outcome measures
Measure
In-person Family Skills Training
n=9 Participants
The index partner participated in intervention as a dyad with a family member with an in-person skills training. Together, Eating and Activity, Matter Plus (TEAM+) In-Person: 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.
Online Family Skills Training
n=6 Participants
The index partner participated in intervention as a dyad with a family member with an online skills training. 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.
Change in Family Cohesion
-0.67 score on a scale
Standard Deviation 4.37
6 score on a scale
Standard Deviation 7.92

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Population: All collected data are reported. Four participants (two from the in-person arm and two from the online arm) did not complete the Family Emotional Involvement and Criticism Scale. Overall Number of Participants Analyzed in this measure includes Index Participants. Family Member who were part of a dyad did not participate in data collection are not included in the reported numbers.

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.

Outcome measures

Outcome measures
Measure
In-person Family Skills Training
n=9 Participants
The index partner participated in intervention as a dyad with a family member with an in-person skills training. Together, Eating and Activity, Matter Plus (TEAM+) In-Person: 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.
Online Family Skills Training
n=6 Participants
The index partner participated in intervention as a dyad with a family member with an online skills training. 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.
Change in Family Emotional Involvement
0.22 score on a scale
Standard Deviation 2.78
2.33 score on a scale
Standard Deviation 3.09

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Population: All collected data are reported. Four participants (two from the in-person arm and two from the online arm) did not complete the Family Emotional Involvement and Criticism Scale. Overall Number of Participants Analyzed in this measure includes Index Participants. Family Member who were part of a dyad did not participate in data collection are not included in the reported numbers.

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.

Outcome measures

Outcome measures
Measure
In-person Family Skills Training
n=9 Participants
The index partner participated in intervention as a dyad with a family member with an in-person skills training. Together, Eating and Activity, Matter Plus (TEAM+) In-Person: 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.
Online Family Skills Training
n=6 Participants
The index partner participated in intervention as a dyad with a family member with an online skills training. 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.
Change in Family Perceived Criticism
-1.67 score on a scale
Standard Deviation 2.98
-1.67 score on a scale
Standard Deviation 4.11

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Population: All collected data are reported. Four participants (two from the in-person arm and two from the online arm) did not complete the Family Problem-Solving Communication Index. Overall Number of Participants Analyzed in this measure includes Index Participants. Family Member who were part of a dyad did not participate in data collection are not included in the reported numbers.

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.

Outcome measures

Outcome measures
Measure
In-person Family Skills Training
n=9 Participants
The index partner participated in intervention as a dyad with a family member with an in-person skills training. Together, Eating and Activity, Matter Plus (TEAM+) In-Person: 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.
Online Family Skills Training
n=6 Participants
The index partner participated in intervention as a dyad with a family member with an online skills training. 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.
Change in Family Collaborative Problem Solving
-0.11 score on a scale
Standard Deviation 3.03
0.67 score on a scale
Standard Deviation 2.23

Adverse Events

In-person Family Skills Training

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Online Family Skills Training

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Candice L. Alick, PhD

Morehouse School of Medicine

Phone: 404-752-1009

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place