Trial Outcomes & Findings for Feasibility Trial of a Problem-Solving Weight Loss Mobile Application (NCT NCT02192905)

NCT ID: NCT02192905

Last Updated: 2018-09-28

Results Overview

Mean total uses of the problem solving function of the mobile application

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 45 participants
• Primary outcome timeframe: 8-week follow-up
• Results posted on: 2018-09-28

Participant Flow

In order to begin the intervention, participants needed to complete: an online eligibility screener, a telephone screening, the consent process, a screening survey, medical clearance, and a webinar. Missing any of these components would be reason for exclusion.

Participant milestones

Measure	Behavioral Weight Loss + Habit Individuals randomized to this condition will receive 8 weeks 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. Diabetes Prevention Program Lifestyle Intervention
Overall Study STARTED	43
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Behavioral Weight Loss + Habit Individuals randomized to this condition will receive 8 weeks 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. Diabetes Prevention Program Lifestyle Intervention
Overall Study Lost to Follow-up	1

Baseline Characteristics

Feasibility Trial of a Problem-Solving Weight Loss Mobile Application

Baseline characteristics by cohort

Measure	Behavioral Weight Loss + Habit n=43 Participants Individuals randomized to this condition will receive 8 weeks 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. Diabetes Prevention Program Lifestyle Intervention
Age, Continuous	37.33 years STANDARD_DEVIATION 11.29 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants
Weight	202.02 pounds STANDARD_DEVIATION 42.6 • n=5 Participants
Social-Problem Solving Inventory-Revised	107.3 Total score STANDARD_DEVIATION 14.75 • n=5 Participants
Facebook Use Uses Facebook 5-6 times per week	9 Participants n=5 Participants
Facebook Use Uses Facebook daily or more	34 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8-week follow-up

Mean total uses of the problem solving function of the mobile application

Outcome measures

Measure	Behavioral Weight Loss + Habit n=43 Participants Participants will receive 8 weeks 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. Diabetes Prevention Program Lifestyle Intervention
Feasibility (Total Uses)	23.7 mean uses of the app Standard Deviation 19

PRIMARY outcome

Timeframe: 8-week follow-up

Total amount of new habits attempted during the study

Outcome measures

Measure	Behavioral Weight Loss + Habit n=43 Participants Participants will receive 8 weeks 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. Diabetes Prevention Program Lifestyle Intervention
Feasibility (Total Habits Attempted)	17.4 mean habits attempted Standard Deviation 11.6

PRIMARY outcome

Timeframe: Baseline

Population: Of the total number of participants screened for this study (n=559), 7.69% (n=43) were enrolled into the intervention.

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)

Outcome measures

Measure	Behavioral Weight Loss + Habit n=559 Participants Participants will receive 8 weeks 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. Diabetes Prevention Program Lifestyle Intervention
Feasibility (Recruitment Rates)	43 Participants

PRIMARY outcome

Timeframe: 8-weeks

Total attendance at groups and total withdrawn from the study

Outcome measures

Measure	Behavioral Weight Loss + Habit n=43 Participants Participants will receive 8 weeks 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. Diabetes Prevention Program Lifestyle Intervention
Feasibility (Retention Rates)	42 Participants

SECONDARY outcome

Timeframe: 8-week follow-up

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.

Outcome measures

Measure	Behavioral Weight Loss + Habit n=43 Participants Participants will receive 8 weeks 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. Diabetes Prevention Program Lifestyle Intervention
Problem Solving Inventory	-.64 Total score Standard Deviation 8.31

SECONDARY outcome

Timeframe: 8-week follow-up

Measured in pounds with a digital scale

Outcome measures

Measure	Behavioral Weight Loss + Habit n=43 Participants Participants will receive 8 weeks 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. Diabetes Prevention Program Lifestyle Intervention
% Weight Change	-1.9 percentage of pounds Standard Deviation 3.0

SECONDARY outcome

Timeframe: 16 week follow-up

Measured in pounds with a digital scale

Outcome measures

Measure	Behavioral Weight Loss + Habit n=43 Participants Participants will receive 8 weeks 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. Diabetes Prevention Program Lifestyle Intervention
% Weight Change	-1.67 percentage of pounds Standard Deviation 7.3

SECONDARY outcome

Timeframe: 16-week follow-up

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.

Outcome measures

Measure	Behavioral Weight Loss + Habit n=43 Participants Participants will receive 8 weeks 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. Diabetes Prevention Program Lifestyle Intervention
Social Problem Solving Inventory	-.76 Total score Standard Deviation 13.07

Adverse Events

Behavioral Weight Loss + Habit

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Behavioral Weight Loss + Habit n=43 participants at risk Participants will receive 8 weeks 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. Diabetes Prevention Program Lifestyle Intervention
General disorders Cold, flu, or virus	14.0% 6/43 • Number of events 6 • Participants were in the study for 16 weeks and were monitored for the occurrence of adverse events throughout the study. Adverse events were documented during the interventions, at the 8-week assessment, and the 16-week assessment.
General disorders Previous condition worsening	4.7% 2/43 • Number of events 2 • Participants were in the study for 16 weeks and were monitored for the occurrence of adverse events throughout the study. Adverse events were documented during the interventions, at the 8-week assessment, and the 16-week assessment.
General disorders Injury	2.3% 1/43 • Number of events 1 • Participants were in the study for 16 weeks and were monitored for the occurrence of adverse events throughout the study. Adverse events were documented during the interventions, at the 8-week assessment, and the 16-week assessment.

Additional Information

Sherry Pagoto, Professor

University of Massachusetts Medical School

Phone: 508-856-5159

Email: study@umassmed.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place