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Becoming United in Lifestyle Decisions (BUILD)

Primary Purpose

Overweight and Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Core Behavioral Weight Loss (BWL) intervention
Dyadic Action Planning
Joint Feedback
Autonomy Support Training
Home Environment Modifications
Sponsored by
University of Connecticut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring couples, mobile weight loss treatment, weight control

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Married/cohabitating couple - both partners must be eligible BMI between 25-55kg/m2 English speaking/reading Have a smartphone and reliable internet access Have active email address Willing to videoconference Exclusion Criteria: Report being unable to walk 2 blocks without stopping Are currently participating in weight loss treatment, have a history of bariatric surgery, or lost ≥5% in the past 6-months Are pregnant or plan to become pregnant during the study period Report chest pain or loss of consciousness on the Physical Activity Readiness Questionnaire Report a medical condition that could jeopardize their safety in a weight control program with diet and exercise guidelines Report conditions that, in the judgment of the PI, would render them unlikely to follow the protocol (e.g. dementia)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm 9

    Arm 10

    Arm 11

    Arm 12

    Arm 13

    Arm 14

    Arm 15

    Arm 16

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Condition 1

    Condition 2

    Condition 3

    Condition 4

    Condition 5

    Condition 6

    Condition 7

    Condition 8

    Condition 9

    Condition 10

    Condition 11

    Condition 12

    Condition 13

    Condition 14

    Condition 15

    Condition 16

    Arm Description

    1) Core BWL Intervention

    1) Core BWL Intervention; 2) Home Environment Modifications

    1) Core BWL Intervention; 2) Autonomy Support Training

    1) Core BWL Intervention; 2) Autonomy Support Training; 3) Home Environment Modifications

    1) Core BWL Intervention; 2) Joint Feedback

    1) Core BWL Intervention; 2) Joint Feedback; 3) Home Environment Modifications

    1) Core BWL Intervention; 2) Joint Feedback; 3) Autonomy Support Training

    1) Core BWL Intervention; 2) Joint Feedback; 3) Autonomy Support Training; 4) Home Environment Modifications

    1) Core BWL Intervention; 2) Dyadic Action Planning

    1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Home Environment Modifications

    1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Autonomy Support Training

    1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Autonomy Support Training 4) Home Environment Modifications

    1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback

    1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback; 4) Home Environment Modifications

    1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback; 4) Autonomy Support Training

    1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback; 4) Autonomy Support Training; 5) Home Environment Modifications

    Outcomes

    Primary Outcome Measures

    Body Weight (kg)
    Weight change from baseline to 6 months. Weight will be objectively measured on a digital scale in the participant's home and weight change will be calculated.

    Secondary Outcome Measures

    Goal Coordination (Wingrove Goal Coordination Scale)
    Goal coordination (the extent to which partners integrate and align their weight management goals) will be measured with the Wingrove Goal Coordination Scale at baseline, 3, and 6 months.
    Transactive Density
    Interdependence of partners will be measured with the Inclusion of Others in the Self Scale at baseline, 3, and 6 months.
    Shared Goal Representation
    The Important Others Questionnaire will be used to capture shared goal representation at baseline, 3, and 6 months.
    Home Food Environment (Household Food Inventory)
    The home food environment will be measured with the Household Food Inventory, administered at baseline, 3, and 6 months.
    Home Exercise Environment (Exercise Environment Questionnaire)
    The home exercise environment will be measured with the Exercise Environment Questionnaire, administered at baseline, 3, and 6 months.
    Dietary Intake
    Dietary intake will be assessed at baseline and 3 months as a hypothesized behavioral mediator and at 6 months as a secondary outcome measure.
    Physical Activity (Paffenbarger Physical Activity Questionnaire)
    Physical activity will be assessed using the Paffenbarger Physical Activity Questionnaire at baseline and 3 months as a hypothesized behavioral mediator and at 6 months as a secondary outcome measure.

    Full Information

    First Posted
    February 22, 2023
    Last Updated
    September 20, 2023
    Sponsor
    University of Connecticut
    Collaborators
    University of North Carolina, Chapel Hill, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05796141
    Brief Title
    Becoming United in Lifestyle Decisions
    Acronym
    BUILD
    Official Title
    Optimizing a Couples-Based mHealth Intervention for Weight Management
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2024 (Anticipated)
    Primary Completion Date
    November 2026 (Anticipated)
    Study Completion Date
    November 2026 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    The goal of this project is to investigate how to enhance the effects of an online-only (mHealth) couples weight loss program. This study will use an innovative methodological framework, the Multiphase Optimization Strategy (MOST), to test four different strategies for weight loss and partner support in addition to a core intervention (i.e., dyadic action planning, joint feedback on goal progress, autonomy support training, and home environment modifications).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight and Obesity
    Keywords
    couples, mobile weight loss treatment, weight control

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    736 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Condition 1
    Arm Type
    Experimental
    Arm Description
    1) Core BWL Intervention
    Arm Title
    Condition 2
    Arm Type
    Experimental
    Arm Description
    1) Core BWL Intervention; 2) Home Environment Modifications
    Arm Title
    Condition 3
    Arm Type
    Experimental
    Arm Description
    1) Core BWL Intervention; 2) Autonomy Support Training
    Arm Title
    Condition 4
    Arm Type
    Experimental
    Arm Description
    1) Core BWL Intervention; 2) Autonomy Support Training; 3) Home Environment Modifications
    Arm Title
    Condition 5
    Arm Type
    Experimental
    Arm Description
    1) Core BWL Intervention; 2) Joint Feedback
    Arm Title
    Condition 6
    Arm Type
    Experimental
    Arm Description
    1) Core BWL Intervention; 2) Joint Feedback; 3) Home Environment Modifications
    Arm Title
    Condition 7
    Arm Type
    Experimental
    Arm Description
    1) Core BWL Intervention; 2) Joint Feedback; 3) Autonomy Support Training
    Arm Title
    Condition 8
    Arm Type
    Experimental
    Arm Description
    1) Core BWL Intervention; 2) Joint Feedback; 3) Autonomy Support Training; 4) Home Environment Modifications
    Arm Title
    Condition 9
    Arm Type
    Experimental
    Arm Description
    1) Core BWL Intervention; 2) Dyadic Action Planning
    Arm Title
    Condition 10
    Arm Type
    Experimental
    Arm Description
    1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Home Environment Modifications
    Arm Title
    Condition 11
    Arm Type
    Experimental
    Arm Description
    1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Autonomy Support Training
    Arm Title
    Condition 12
    Arm Type
    Experimental
    Arm Description
    1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Autonomy Support Training 4) Home Environment Modifications
    Arm Title
    Condition 13
    Arm Type
    Experimental
    Arm Description
    1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback
    Arm Title
    Condition 14
    Arm Type
    Experimental
    Arm Description
    1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback; 4) Home Environment Modifications
    Arm Title
    Condition 15
    Arm Type
    Experimental
    Arm Description
    1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback; 4) Autonomy Support Training
    Arm Title
    Condition 16
    Arm Type
    Experimental
    Arm Description
    1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback; 4) Autonomy Support Training; 5) Home Environment Modifications
    Intervention Type
    Behavioral
    Intervention Name(s)
    Core Behavioral Weight Loss (BWL) intervention
    Intervention Description
    Behavioral weight loss core (lessons, self weighing, self-monitoring, individual action planning, feedback and progress check ins)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Dyadic Action Planning
    Intervention Description
    Participants will develop dyadic action plans together.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Joint Feedback
    Intervention Description
    Participants will see data on their partner's progress, in addition to their own weight and behavioral data.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Autonomy Support Training
    Intervention Description
    Participants will receive training in how to create an autonomy supportive environment within their marriage/partnership.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Home Environment Modifications
    Intervention Description
    Participants will be trained in how to structure their home environment to support health behavior.
    Primary Outcome Measure Information:
    Title
    Body Weight (kg)
    Description
    Weight change from baseline to 6 months. Weight will be objectively measured on a digital scale in the participant's home and weight change will be calculated.
    Time Frame
    Baseline to 6 months
    Secondary Outcome Measure Information:
    Title
    Goal Coordination (Wingrove Goal Coordination Scale)
    Description
    Goal coordination (the extent to which partners integrate and align their weight management goals) will be measured with the Wingrove Goal Coordination Scale at baseline, 3, and 6 months.
    Time Frame
    Baseline, 3 months, 6 months
    Title
    Transactive Density
    Description
    Interdependence of partners will be measured with the Inclusion of Others in the Self Scale at baseline, 3, and 6 months.
    Time Frame
    Baseline, 3 months, 6 months
    Title
    Shared Goal Representation
    Description
    The Important Others Questionnaire will be used to capture shared goal representation at baseline, 3, and 6 months.
    Time Frame
    Baseline, 3 months, 6 months
    Title
    Home Food Environment (Household Food Inventory)
    Description
    The home food environment will be measured with the Household Food Inventory, administered at baseline, 3, and 6 months.
    Time Frame
    Baseline, 3 months, 6 months
    Title
    Home Exercise Environment (Exercise Environment Questionnaire)
    Description
    The home exercise environment will be measured with the Exercise Environment Questionnaire, administered at baseline, 3, and 6 months.
    Time Frame
    Baseline, 3 months, 6 months
    Title
    Dietary Intake
    Description
    Dietary intake will be assessed at baseline and 3 months as a hypothesized behavioral mediator and at 6 months as a secondary outcome measure.
    Time Frame
    Baseline, 3 months, 6 months
    Title
    Physical Activity (Paffenbarger Physical Activity Questionnaire)
    Description
    Physical activity will be assessed using the Paffenbarger Physical Activity Questionnaire at baseline and 3 months as a hypothesized behavioral mediator and at 6 months as a secondary outcome measure.
    Time Frame
    Baseline, 3 months, 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Married/cohabitating couple - both partners must be eligible BMI between 25-55kg/m2 English speaking/reading Have a smartphone and reliable internet access Have active email address Willing to videoconference Exclusion Criteria: Report being unable to walk 2 blocks without stopping Are currently participating in weight loss treatment, have a history of bariatric surgery, or lost ≥5% in the past 6-months Are pregnant or plan to become pregnant during the study period Report chest pain or loss of consciousness on the Physical Activity Readiness Questionnaire Report a medical condition that could jeopardize their safety in a weight control program with diet and exercise guidelines Report conditions that, in the judgment of the PI, would render them unlikely to follow the protocol (e.g. dementia)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zeely Denmat, BS
    Phone
    860-455-3842
    Email
    zeely.denmat@uconn.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Becoming United in Lifestyle Decisions

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