Feasibility Trial of a Problem-Solving Weight Loss Mobile Application
2 other identifiers
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Dec 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2014
CompletedFirst Posted
Study publicly available on registry
July 17, 2014
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedResults Posted
Study results publicly available
February 22, 2018
CompletedSeptember 28, 2018
September 1, 2018
1.1 years
June 11, 2014
September 5, 2017
September 26, 2018
Conditions
Outcome Measures
Primary Outcomes (4)
Feasibility (Total Uses)
Mean total uses of the problem solving function of the mobile application
8-week follow-up
Feasibility (Total Habits Attempted)
Total amount of new habits attempted during the study
8-week follow-up
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)
Baseline
Feasibility (Retention Rates)
Total attendance at groups and total withdrawn from the study
8-weeks
Secondary Outcomes (4)
Problem Solving Inventory
8-week follow-up
% Weight Change
8-week follow-up
% Weight Change
16 week follow-up
Social Problem Solving Inventory
16-week follow-up
Study Arms (1)
Behavioral Weight Loss + Habit
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Connecticutlead
- Worcester Polytechnic Institutecollaborator
Study Sites (1)
University of Connecticut
Storrs, Connecticut, 06269, United States
Related Publications (1)
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.
PMID: 29925496DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sherry Pagoto, Professor
- Organization
- University of Massachusetts Medical School
Study Officials
- PRINCIPAL INVESTIGATOR
Sherry L Pagoto, PhD
University of Connecticut
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 11, 2014
First Posted
July 17, 2014
Study Start
December 1, 2015
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
September 28, 2018
Results First Posted
February 22, 2018
Record last verified: 2018-09