Feasibility Trial of a Problem-Solving Weight Loss Mobile Application

September 26, 2018 updated by: Sherry Pagoto, University of Connecticut
The purpose of this research was to develop and test the feasibility of Habit, a weight loss mobile application that was designed to coach patients through their weight loss challenges. In a pilot trial in 43 obese participants, investigators tested the feasibility of the Smart Coach mobile application when paired with a shortened online-delivered (8-week) behavioral weight loss intervention. Feasibility outcomes included frequency and duration of usage of the mobile app and each feature, recruitment, and retention. Post-intervention focus groups discussed the feasibility and acceptability of the intervention. The investigators also performed exploratory analyses comparing conditions on problem solving skills and weight loss at 8 and 16 weeks, which will inform a subsequent randomized controlled efficacy trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators developed and tested the feasibility of Habit, a weight loss mobile app that includes common features such as self-monitoring, goal setting, and a social network, but even more importantly, an avatar-facilitated, idiographic problem solving feature that processes information intelligently to help patients identify solutions to their weight loss problems. In a pilot trial in 43 obese participants, investigators tested the feasibility of the Habit mobile application when paired with a shortened (8 week) behavioral weight loss intervention. Feasibility outcomes included frequency and duration of usage of the mobile app and each feature, recruitment, and retention. The investigators also performed analyses on problem solving skills and weight loss at 8 and 16 weeks, which will inform a subsequent randomized controlled efficacy trial. Data will support an efficacy trial of a Habit-assisted brief behavioral weight loss intervention relative to a brief behavioral weight loss intervention alone with 1 year follow-up. The investigators overarching goal is to develop mobile technology that reduces the intensity of lifestyle interventions as far as possible while preserving weight loss outcomes, to ultimately broaden reach.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Storrs, Connecticut, United States, 06269
        • University of Connecticut

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion: Participants must 1) have a BMI between 30 and 45, 2) currently uses a smartphone with Android software, 3) have connectivity to the internet at home and work, 4) have PCP written clearance, and 5) age 18 or older.

Exclusion:

  1. Ages <18
  2. BMI <30 and >45
  3. Does not currently use a smart phone with Android software version 4.4 or later
  4. Does not use a smartphone supported by the app (will assess model and type of phone for each participant)
  5. Does not have connectivity to the internet at home and work; or wifi access at home
  6. Does not use smart phone regularly throughout the day
  7. Has not used Android smartphone for at least a year
  8. Has not used a weight loss mobile app in the last 6 months
  9. Does not have a Facebook account, uses it infrequently, or does not actively engage on Facebook
  10. Does not have a gmail account or is unwilling to create one
  11. Does not have PCP written clearance
  12. Bipolar disorder, substance abuse, psychosis, bulimia, or severe depression
  13. Pregnant or lactating
  14. Had bariatric surgery
  15. Medication affecting weight
  16. Adults unwilling to provide consent
  17. Prisoners
  18. Unable to read or understand English
  19. Has type 1 or 2 diabetes
  20. Have concerns about being audiotaped
  21. Unable to walk unaided
  22. Has any medical condition that precludes lifestyle changes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavioral Weight Loss + Habit
Participants will receive 8 week of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.
Behavioral: Diabetes Prevention Program Lifestyle Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility (Total Uses)
Time Frame: 8-week follow-up
Mean total uses of the problem solving function of the mobile application
8-week follow-up
Feasibility (Total Habits Attempted)
Time Frame: 8-week follow-up
Total amount of new habits attempted during the study
8-week follow-up
Feasibility (Recruitment Rates)
Time Frame: Baseline
Recruitment rates include the total number of participants contacting us to participate, which includes the intervention participants plus those screened out prior to starting the intervention (Total screened = 559; Total intervention participants = 43)
Baseline
Feasibility (Retention Rates)
Time Frame: 8-weeks
Total attendance at groups and total withdrawn from the study
8-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Problem Solving Inventory
Time Frame: 8-week follow-up
The social problem solving inventory measures strengths and weaknesses in ability to solve problems in all areas of life. The measure includes sub scales (positive problem orientation, rational problem-solving, negative problem orientation, impulsivity/carelessness style, and avoidance style). The means of the subscales are summed and then matched against an age chart to achieve the total score for the age being studied. This is done for each participant. The scoring range is 28 to 140. The higher the score the higher the problem solving ability.The change from baseline to 8-weeks is calculated by subtracting the baseline score from the 8 week score and then doing a 1-sample t-test of whether or not the change was different than 0.
8-week follow-up
% Weight Change
Time Frame: 8-week follow-up
Measured in pounds with a digital scale
8-week follow-up
% Weight Change
Time Frame: 16 week follow-up
Measured in pounds with a digital scale
16 week follow-up
Social Problem Solving Inventory
Time Frame: 16-week follow-up
The social problem solving inventory measures strengths and weaknesses in ability to solve problems in all areas of life. The measure includes sub scales (positive problem orientation, rational problem-solving, negative problem orientation, impulsivity/carelessness style, and avoidance style). The means of the subscales are summed and then matched against an age chart to achieve the total score for the age being studied. This is done for each participant. The scoring range is 28 to 140. The higher the score the higher the problem solving ability. The change from baseline to 16-weeks is calculated by subtracting the baseline score from the 16 week score and then doing a 1-sample t-test of whether or not the change was different than 0.
16-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Connecticut

Collaborators

Worcester Polytechnic Institute

Investigators

  • Principal Investigator: Sherry L Pagoto, PhD, University of Connecticut

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

June 11, 2014

First Submitted That Met QC Criteria

July 15, 2014

First Posted (Estimate)

July 17, 2014

Study Record Updates

Last Update Posted (Actual)

September 28, 2018

Last Update Submitted That Met QC Criteria

September 26, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H17-237
  • 1R21DK098556-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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