Behavior, Eating, Body Weight, Body Weight Changes, Chronic Disease, Obesity, Overweight, Overweight and Obesity, Physical Inactivity, Weight Loss, Weight Reduction
Conditions
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).
Interventions
BEHAVIORALTogether, 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.
BEHAVIORALTogether, 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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Splendor-NC
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | Baseline, 12 weeks | Body weight (kg) expressed as a continuous variable will be collected on a digital scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Regulation of Eating Behaviors | 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. |
| Change in Self-Efficacy of Eating Behaviors | 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. |
| Change in Social Support Effectiveness | 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. |
| Change in Social Support for Eating | 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. |
| Change in Social Support for Exercise | 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. |
| Change in Body Mass Index (BMI) | Baseline,12 weeks | Body mass index calculated from kg/m\^2. |
| Change in Family Cohesion | 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. |
| Change in Family Emotional Involvement | 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. |
| Change in Family Perceived Criticism | 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. |
| Change in Family Collaborative Problem Solving | 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. |
| Change in Family Communication | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| In-person Family Skills Training 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. | 11 |
| Online Family Skills Training 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. | 8 |
| Total | 19 |
Baseline characteristics
| Characteristic | In-person Family Skills Training | Total | Online Family Skills Training |
|---|---|---|---|
| Age, Continuous | 44.27 years STANDARD_DEVIATION 13.76 | 49.58 years STANDARD_DEVIATION 14.05 | 54.13 years STANDARD_DEVIATION 13.15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 19 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 19 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 11 Participants | 19 Participants | 8 Participants |
| Sex: Female, Male Female | 6 Participants | 12 Participants | 6 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 8 |
| other Total, other adverse events | 0 / 11 | 0 / 8 |
| serious Total, serious adverse events | 0 / 11 | 0 / 8 |
Outcome results
Primary
Change in Body Weight
Body weight (kg) expressed as a continuous variable will be collected on a digital scale.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-person Family Skills Training | Change in Body Weight | -0.91 kg | Standard Deviation 4.83 |
| Online Family Skills Training | Change in Body Weight | -2.92 kg | Standard Deviation 4.04 |
Secondary
Change in Body Mass Index (BMI)
Body mass index calculated from kg/m\^2.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-person Family Skills Training | Change in Body Mass Index (BMI) | -0.27 kg/m^2 | Standard Deviation 2.05 |
| Online Family Skills Training | Change in Body Mass Index (BMI) | -0.77 kg/m^2 | Standard Deviation 1.33 |
Secondary
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-person Family Skills Training | Change in Family Cohesion | -0.67 score on a scale | Standard Deviation 4.37 |
| Online Family Skills Training | Change in Family Cohesion | 6 score on a scale | Standard Deviation 7.92 |
Secondary
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-person Family Skills Training | Change in Family Collaborative Problem Solving | -0.11 score on a scale | Standard Deviation 3.03 |
| Online Family Skills Training | Change in Family Collaborative Problem Solving | 0.67 score on a scale | Standard Deviation 2.23 |
Secondary
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-person Family Skills Training | Change in Family Communication | 0 score on a scale | Standard Deviation 1.7 |
| Online Family Skills Training | Change in Family Communication | 1.67 score on a scale | Standard Deviation 3.86 |
Secondary
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-person Family Skills Training | Change in Family Emotional Involvement | 0.22 score on a scale | Standard Deviation 2.78 |
| Online Family Skills Training | Change in Family Emotional Involvement | 2.33 score on a scale | Standard Deviation 3.09 |
Secondary
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-person Family Skills Training | Change in Family Perceived Criticism | -1.67 score on a scale | Standard Deviation 2.98 |
| Online Family Skills Training | Change in Family Perceived Criticism | -1.67 score on a scale | Standard Deviation 4.11 |
Secondary
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-person Family Skills Training | Change in Self-Efficacy of Eating Behaviors | 13.63 units on a scale | Standard Deviation 18.02 |
| Online Family Skills Training | Change in Self-Efficacy of Eating Behaviors | 9.43 units on a scale | Standard Deviation 27.4 |
Secondary
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-person Family Skills Training | Change in Self-Regulation of Eating Behaviors | 7.2 score on a scale | Standard Deviation 11.21 |
| Online Family Skills Training | Change in Self-Regulation of Eating Behaviors | 9.29 score on a scale | Standard Deviation 11.28 |
Secondary
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-person Family Skills Training | Change in Social Support Effectiveness | 2.67 score on a scale | Standard Deviation 10.07 |
| Online Family Skills Training | Change in Social Support Effectiveness | -9.0 score on a scale | Standard Deviation 6.14 |
Secondary
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-person Family Skills Training | Change in Social Support for Eating | 24.1 score on a scale | Standard Deviation 14.22 |
| Online Family Skills Training | Change in Social Support for Eating | 30.43 score on a scale | Standard Deviation 13.8 |
Secondary
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-person Family Skills Training | Change in Social Support for Exercise | -0.8 score on a scale | Standard Deviation 11.46 |
| Online Family Skills Training | Change in Social Support for Exercise | 1.67 score on a scale | Standard Deviation 9.53 |