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Feasibility Trial of a Problem-Solving Weight Loss Mobile Application

Primary Purpose

Obesity, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diabetes Prevention Program Lifestyle Intervention
Sponsored by
University of Connecticut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

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

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

Sites / Locations

  • University of Connecticut

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Behavioral Weight Loss + Habit

Arm Description

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.

Outcomes

Primary Outcome Measures

Feasibility (Total Uses)
Mean total uses of the problem solving function of the mobile application
Feasibility (Total Habits Attempted)
Total amount of new habits attempted during the study
Feasibility (Recruitment Rates)
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)
Feasibility (Retention Rates)
Total attendance at groups and total withdrawn from the study

Secondary Outcome Measures

Problem Solving Inventory
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.
% Weight Change
Measured in pounds with a digital scale
% Weight Change
Measured in pounds with a digital scale
Social Problem Solving Inventory
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.

Full Information

First Posted
June 11, 2014
Last Updated
September 26, 2018
Sponsor
University of Connecticut
Collaborators
Worcester Polytechnic Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02192905
Brief Title
Feasibility Trial of a Problem-Solving Weight Loss Mobile Application
Official Title
Feasibility Trial of a Problem-Solving Weight Loss Mobile Application
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Connecticut
Collaborators
Worcester Polytechnic Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Weight Loss + Habit
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Prevention Program Lifestyle Intervention
Primary Outcome Measure Information:
Title
Feasibility (Total Uses)
Description
Mean total uses of the problem solving function of the mobile application
Time Frame
8-week follow-up
Title
Feasibility (Total Habits Attempted)
Description
Total amount of new habits attempted during the study
Time Frame
8-week follow-up
Title
Feasibility (Recruitment Rates)
Description
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)
Time Frame
Baseline
Title
Feasibility (Retention Rates)
Description
Total attendance at groups and total withdrawn from the study
Time Frame
8-weeks
Secondary Outcome Measure Information:
Title
Problem Solving Inventory
Description
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.
Time Frame
8-week follow-up
Title
% Weight Change
Description
Measured in pounds with a digital scale
Time Frame
8-week follow-up
Title
% Weight Change
Description
Measured in pounds with a digital scale
Time Frame
16 week follow-up
Title
Social Problem Solving Inventory
Description
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.
Time Frame
16-week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: Ages <18 BMI <30 and >45 Does not currently use a smart phone with Android software version 4.4 or later Does not use a smartphone supported by the app (will assess model and type of phone for each participant) Does not have connectivity to the internet at home and work; or wifi access at home Does not use smart phone regularly throughout the day Has not used Android smartphone for at least a year Has not used a weight loss mobile app in the last 6 months Does not have a Facebook account, uses it infrequently, or does not actively engage on Facebook Does not have a gmail account or is unwilling to create one Does not have PCP written clearance Bipolar disorder, substance abuse, psychosis, bulimia, or severe depression Pregnant or lactating Had bariatric surgery Medication affecting weight Adults unwilling to provide consent Prisoners Unable to read or understand English Has type 1 or 2 diabetes Have concerns about being audiotaped Unable to walk unaided Has any medical condition that precludes lifestyle changes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherry L Pagoto, PhD
Organizational Affiliation
University of Connecticut
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut
City
Storrs
State/Province
Connecticut
ZIP/Postal Code
06269
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29925496
Citation
Pagoto S, Tulu B, Agu E, Waring ME, Oleski JL, Jake-Schoffman DE. Using the Habit App for Weight Loss Problem Solving: Development and Feasibility Study. JMIR Mhealth Uhealth. 2018 Jun 20;6(6):e145. doi: 10.2196/mhealth.9801.
Results Reference
derived

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Feasibility Trial of a Problem-Solving Weight Loss Mobile Application

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