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Online Family Dyadic Skills Training for Black Adults in Behavioral Weight Loss Program (TEAM+)

Primary Purpose

Body Weight, Body Weight Changes, Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Together, Eating and Activity, Matter Plus (TEAM+) Online
Together, Eating and Activity, Matter Plus (TEAM+) In-Person
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Body Weight

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Center for Health Promotion and Disease Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

In-person Family Skills Training

Online Family Skills Training

Arm Description

The index partner will participate in intervention as a dyad with a family member with an in-person skills training.

The index partner will participate in intervention as a dyad with a family member with an online skills training.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Waist Circumference
Measured in a standing position, at midpoint between the lower border of the last rib and the upper border of the iliac crest on the horizontal place, using an inextensible Gulick measuring tape graduated in cm.
Change in Body Mass Index (BMI)
Body mass index calculated from kg/m^2.
Mean Change in Blood Pressure
Blood Pressure measured after 5 minutes of rest and taken in the same position throughout the study.
Change in Caloric Intake
To assess behavioral change the Automated-Self Administered Recall System (ASA24) will be used to determine daily kcal.
Change in Physical Activity
The Paffenbarger Physical Activity Questionnaire (PPAQ) is an eight-item questionnaire that is scored by measuring minutes per week of Moderate to Vigorous Physical Activity (MVPA) by adding block per day and and physical activity of at least moderate level; not measured on a scale.
Change in Self-Regulation of Eating Behaviors
The Eating Behavior Inventory (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.
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.
Change in Self-Efficacy of Physical Activity
The confidence subscale of the Patient-centered Assessment and Counseling for Exercise Adult Diet and Physical Activity Measure (6 items; ) measures confidence in participating in regular exercise or physical activity in different situations (e.g., "How confident are you that you would participate in regular exercise or physical activity: When I am tired?"). Items rated on a scale from 1 ("not at all confident") to 6 ("extremely confident"). Higher scores show higher self-efficacy.
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. Total scores range from 0 to 80, with higher scores indicating more effective support.
Change in Social Support for Eating
The Social Support and Eating Habits Survey (10 items) measures social support specific to healthy eating. Subscales 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
The exercise participation subscale of the Social Support and Exercise Survey (10 items) measures social support specific to exercise behaviors. The subscale assesses 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 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." Higher scores represent unhealthy communication.
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."
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, as above.
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, as above.
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. Consisting of 2 subscales, affirmatory communication and incendiary communication, the response options were "false," "mostly false," "mostly true," and "true."

Full Information

First Posted
July 31, 2023
Last Updated
July 31, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Splendor-NC
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1. Study Identification

Unique Protocol Identification Number
NCT05981508
Brief Title
Online Family Dyadic Skills Training for Black Adults in Behavioral Weight Loss Program
Acronym
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+)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Splendor-NC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight, Body Weight Changes, Obesity, Overweight and Obesity, Overweight, Behavior, Eating, Physical Inactivity, Chronic Disease, Weight Loss, Weight Reduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
In-person Family Skills Training
Arm Type
Active Comparator
Arm Description
The index partner will participate in intervention as a dyad with a family member with an in-person skills training.
Arm Title
Online Family Skills Training
Arm Type
Experimental
Arm Description
The index partner will participate in intervention as a dyad with a family member with an online skills training.
Intervention Type
Behavioral
Intervention Name(s)
Together, Eating and Activity, Matter Plus (TEAM+) Online
Other Intervention Name(s)
TEAM +
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Together, Eating and Activity, Matter Plus (TEAM+) In-Person
Other Intervention Name(s)
TEAM +
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Body Weight
Description
Body weight (kg) expressed as a continuous variable will be collected on a digital scale.
Time Frame
Baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Change in Waist Circumference
Description
Measured in a standing position, at midpoint between the lower border of the last rib and the upper border of the iliac crest on the horizontal place, using an inextensible Gulick measuring tape graduated in cm.
Time Frame
Baseline,12 weeks
Title
Change in Body Mass Index (BMI)
Description
Body mass index calculated from kg/m^2.
Time Frame
Baseline,12 weeks
Title
Mean Change in Blood Pressure
Description
Blood Pressure measured after 5 minutes of rest and taken in the same position throughout the study.
Time Frame
Baseline,12 weeks
Title
Change in Caloric Intake
Description
To assess behavioral change the Automated-Self Administered Recall System (ASA24) will be used to determine daily kcal.
Time Frame
Baseline,12 weeks
Title
Change in Physical Activity
Description
The Paffenbarger Physical Activity Questionnaire (PPAQ) is an eight-item questionnaire that is scored by measuring minutes per week of Moderate to Vigorous Physical Activity (MVPA) by adding block per day and and physical activity of at least moderate level; not measured on a scale.
Time Frame
Baseline,12 weeks
Title
Change in Self-Regulation of Eating Behaviors
Description
The Eating Behavior Inventory (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.
Time Frame
Baseline,12 weeks
Title
Change in Self-Efficacy of Eating Behaviors
Description
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.
Time Frame
Baseline,12 weeks
Title
Change in Self-Efficacy of Physical Activity
Description
The confidence subscale of the Patient-centered Assessment and Counseling for Exercise Adult Diet and Physical Activity Measure (6 items; ) measures confidence in participating in regular exercise or physical activity in different situations (e.g., "How confident are you that you would participate in regular exercise or physical activity: When I am tired?"). Items rated on a scale from 1 ("not at all confident") to 6 ("extremely confident"). Higher scores show higher self-efficacy.
Time Frame
Baseline,12 weeks
Title
Change in Social Support Effectiveness
Description
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. Total scores range from 0 to 80, with higher scores indicating more effective support.
Time Frame
Baseline,12 weeks
Title
Change in Social Support for Eating
Description
The Social Support and Eating Habits Survey (10 items) measures social support specific to healthy eating. Subscales 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
Title
Change in Social Support for Exercise
Description
The exercise participation subscale of the Social Support and Exercise Survey (10 items) measures social support specific to exercise behaviors. The subscale assesses 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
Title
Change in Family Communication
Description
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." Higher scores represent unhealthy communication.
Time Frame
Baseline, 12 weeks
Title
Change in Family Cohesion
Description
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."
Time Frame
Baseline, 12 weeks
Title
Change in Family Emotional Involvement
Description
The family emotional involvement (7 items) of the Family Emotional Involvement and Criticism Scale rate items on a 5-point Likert scale, as above.
Time Frame
Baseline, 12 weeks
Title
Change in Family Perceived Criticism
Description
The perceived criticism (7 items) subscales of the Family Emotional Involvement and Criticism Scale rate items like on a 5-point Likert scale, as above.
Time Frame
Baseline, 12 weeks
Title
Change in Family Collaborative problem solving
Description
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. Consisting of 2 subscales, affirmatory communication and incendiary communication, the response options were "false," "mostly false," "mostly true," and "true."
Time Frame
Baseline, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Candice Alick, PhD, MS
Phone
919-966-6080
Email
alick@email.unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Candice Alick, PhD, MS
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Health Promotion and Disease Prevention
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27499
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Candice Alick, PhD, MS
Phone
919-966-6080
Email
alick@email.unc.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
beginning 9 and continuing for 36 months following publication
IPD Sharing Access Criteria
Investigator has approved from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

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

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