NCT05796141

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
736

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Mar 2024Nov 2026

First Submitted

Initial submission to the registry

February 22, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

March 13, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

2.6 years

First QC Date

February 22, 2023

Last Update Submit

April 23, 2025

Conditions

Keywords

couplesmobile weight loss treatmentweight control

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to 6 months

Secondary Outcomes (7)

  • Goal Coordination (Wingrove Goal Coordination Scale)

    Baseline, 3 months, 6 months

  • Transactive Density

    Baseline, 3 months, 6 months

  • Shared Goal Representation

    Baseline, 3 months, 6 months

  • Home Food Environment (Household Food Inventory)

    Baseline, 3 months, 6 months

  • Home Exercise Environment (Exercise Environment Questionnaire)

    Baseline, 3 months, 6 months

  • +2 more secondary outcomes

Study Arms (16)

Condition 1

EXPERIMENTAL

1\) Core BWL Intervention

Behavioral: Core Behavioral Weight Loss (BWL) intervention

Condition 2

EXPERIMENTAL

1\) Core BWL Intervention; 2) Home Environment Modifications

Behavioral: Core Behavioral Weight Loss (BWL) interventionBehavioral: Home Environment Modifications

Condition 3

EXPERIMENTAL

1\) Core BWL Intervention; 2) Autonomy Support Training

Behavioral: Core Behavioral Weight Loss (BWL) interventionBehavioral: Autonomy Support Training

Condition 4

EXPERIMENTAL

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

Behavioral: Core Behavioral Weight Loss (BWL) interventionBehavioral: Autonomy Support TrainingBehavioral: Home Environment Modifications

Condition 5

EXPERIMENTAL

1\) Core BWL Intervention; 2) Joint Feedback

Behavioral: Core Behavioral Weight Loss (BWL) interventionBehavioral: Joint Feedback

Condition 6

EXPERIMENTAL

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

Behavioral: Core Behavioral Weight Loss (BWL) interventionBehavioral: Joint FeedbackBehavioral: Home Environment Modifications

Condition 7

EXPERIMENTAL

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

Behavioral: Core Behavioral Weight Loss (BWL) interventionBehavioral: Joint FeedbackBehavioral: Autonomy Support Training

Condition 8

EXPERIMENTAL

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

Behavioral: Core Behavioral Weight Loss (BWL) interventionBehavioral: Joint FeedbackBehavioral: Autonomy Support TrainingBehavioral: Home Environment Modifications

Condition 9

EXPERIMENTAL

1\) Core BWL Intervention; 2) Dyadic Action Planning

Behavioral: Core Behavioral Weight Loss (BWL) interventionBehavioral: Dyadic Action Planning

Condition 10

EXPERIMENTAL

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

Behavioral: Core Behavioral Weight Loss (BWL) interventionBehavioral: Dyadic Action PlanningBehavioral: Home Environment Modifications

Condition 11

EXPERIMENTAL

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

Behavioral: Core Behavioral Weight Loss (BWL) interventionBehavioral: Dyadic Action PlanningBehavioral: Autonomy Support Training

Condition 12

EXPERIMENTAL

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

Behavioral: Core Behavioral Weight Loss (BWL) interventionBehavioral: Dyadic Action PlanningBehavioral: Autonomy Support TrainingBehavioral: Home Environment Modifications

Condition 13

EXPERIMENTAL

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

Behavioral: Core Behavioral Weight Loss (BWL) interventionBehavioral: Dyadic Action PlanningBehavioral: Joint Feedback

Condition 14

EXPERIMENTAL

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

Behavioral: Core Behavioral Weight Loss (BWL) interventionBehavioral: Dyadic Action PlanningBehavioral: Joint FeedbackBehavioral: Home Environment Modifications

Condition 15

EXPERIMENTAL

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

Behavioral: Core Behavioral Weight Loss (BWL) interventionBehavioral: Dyadic Action PlanningBehavioral: Joint FeedbackBehavioral: Autonomy Support Training

Condition 16

EXPERIMENTAL

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

Behavioral: Core Behavioral Weight Loss (BWL) interventionBehavioral: Dyadic Action PlanningBehavioral: Joint FeedbackBehavioral: Autonomy Support TrainingBehavioral: Home Environment Modifications

Interventions

Behavioral weight loss core (lessons, self weighing, self-monitoring, individual action planning, feedback and progress check ins)

Condition 1Condition 10Condition 11Condition 12Condition 13Condition 14Condition 15Condition 16Condition 2Condition 3Condition 4Condition 5Condition 6Condition 7Condition 8Condition 9

Participants will develop dyadic action plans together.

Condition 10Condition 11Condition 12Condition 13Condition 14Condition 15Condition 16Condition 9
Joint FeedbackBEHAVIORAL

Participants will see data on their partner's progress, in addition to their own weight and behavioral data.

Condition 13Condition 14Condition 15Condition 16Condition 5Condition 6Condition 7Condition 8

Participants will receive training in how to create an autonomy supportive environment within their marriage/partnership.

Condition 11Condition 12Condition 15Condition 16Condition 3Condition 4Condition 7Condition 8

Participants will be trained in how to structure their home environment to support health behavior.

Condition 10Condition 12Condition 14Condition 16Condition 2Condition 4Condition 6Condition 8

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UConn's Weight Management Research Group

Hartford, Connecticut, 06103, United States

RECRUITING

MeSH Terms

Conditions

OverweightObesity

Interventions

Methods

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Zeely Denmat, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Provost for Health Sciences and Interdisciplinary Initiatives

Study Record Dates

First Submitted

February 22, 2023

First Posted

April 3, 2023

Study Start

March 13, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

April 27, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations