Feasibility Trial of a Problem-Solving Weight Loss Mobile Application

NCT ID: NCT02192905

Last Updated: 2018-09-28

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-01-31

Brief Summary

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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

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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.

Conditions

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Obesity Weight Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Diabetes Prevention Program Lifestyle Intervention

Intervention Type BEHAVIORAL

Interventions

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Diabetes Prevention Program Lifestyle Intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Worcester Polytechnic Institute

OTHER

Sponsor Role collaborator

University of Connecticut

OTHER

Sponsor Role lead

Responsible Party

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Sherry Pagoto

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sherry L Pagoto, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut

Locations

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University of Connecticut

Storrs, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29925496 (View on PubMed)

Other Identifiers

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1R21DK098556-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H17-237

Identifier Type: -

Identifier Source: org_study_id

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