Clinical trial NCT02192905: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: Worcester Polytechnic Institute
First posted: 2014-07-17
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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:

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

Primary outcomes:
measure: Feasibility (Total Uses)
timeFrame: 8-week follow-up
measure: Feasibility (Total Habits Attempted)
timeFrame: 8-week follow-up
measure: Feasibility (Recruitment Rates)
timeFrame: Baseline
measure: Feasibility (Retention Rates)
timeFrame: 8-weeks
Secondary outcomes:
measure: Problem Solving Inventory
timeFrame: 8-week follow-up
measure: % Weight Change
timeFrame: 8-week follow-up
measure: % Weight Change
timeFrame: 16 week follow-up
measure: Social Problem Solving Inventory
timeFrame: 16-week follow-up
Other outcomes:
Locations:
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Sherry L Pagoto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.