Feasibility Trial of a Problem-Solving Weight Loss Mobile Application

Obesity Clinical Trial

Official title:

Feasibility Trial of a Problem-Solving Weight Loss Mobile Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02192905
• Other study ID #: H17-237
• Secondary ID: 1R21DK098556-01
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: January 2017

Study information

• Verified date: September 2018
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Weight Loss

Intervention

Behavioral:
• Diabetes Prevention Program Lifestyle Intervention

Locations

Country	Name	City	State
United States	University of Connecticut	Storrs	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut	Worcester Polytechnic Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility (Total Uses)	Mean total uses of the problem solving function of the mobile application	8-week follow-up
Primary	Feasibility (Total Habits Attempted)	Total amount of new habits attempted during the study	8-week follow-up
Primary	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
Primary	Feasibility (Retention Rates)	Total attendance at groups and total withdrawn from the study	8-weeks
Secondary	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.	8-week follow-up
Secondary	% Weight Change	Measured in pounds with a digital scale	8-week follow-up
Secondary	% Weight Change	Measured in pounds with a digital scale	16 week follow-up
Secondary	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.	16-week follow-up