Obesity, Weight Loss
Conditions
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.
Interventions
BEHAVIORALDiabetes Prevention Program Lifestyle Intervention
Sponsors
Worcester Polytechnic Institute
University of Connecticut
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility (Total Uses) | 8-week follow-up | Mean total uses of the problem solving function of the mobile application |
| Feasibility (Total Habits Attempted) | 8-week follow-up | Total amount of new habits attempted during the study |
| Feasibility (Recruitment Rates) | Baseline | 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) |
| Feasibility (Retention Rates) | 8-weeks | Total attendance at groups and total withdrawn from the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| % Weight Change | 8-week follow-up | Measured in pounds with a digital scale |
| Social Problem Solving Inventory | 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. |
| Problem Solving Inventory | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 43 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Behavioral Weight Loss + Habit |
|---|---|
| Age, Continuous | 37.33 years STANDARD_DEVIATION 11.29 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Facebook Use Uses Facebook 5-6 times per week | 9 Participants |
| Facebook Use Uses Facebook daily or more | 34 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 35 Participants |
| Region of Enrollment United States | 43 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 14 Participants |
| Social-Problem Solving Inventory-Revised | 107.3 Total score STANDARD_DEVIATION 14.75 |
| Weight | 202.02 pounds STANDARD_DEVIATION 42.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 43 |
| other Total, other adverse events | 9 / 43 |
| serious Total, serious adverse events | 0 / 43 |
Outcome results
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)
Time frame: Baseline
Population: Of the total number of participants screened for this study (n=559), 7.69% (n=43) were enrolled into the intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavioral Weight Loss + Habit | Feasibility (Recruitment Rates) | 43 Participants |
Primary
Feasibility (Retention Rates)
Total attendance at groups and total withdrawn from the study
Time frame: 8-weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavioral Weight Loss + Habit | Feasibility (Retention Rates) | 42 Participants |
Primary
Feasibility (Total Habits Attempted)
Total amount of new habits attempted during the study
Time frame: 8-week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Weight Loss + Habit | Feasibility (Total Habits Attempted) | 17.4 mean habits attempted | Standard Deviation 11.6 |
Primary
Feasibility (Total Uses)
Mean total uses of the problem solving function of the mobile application
Time frame: 8-week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Weight Loss + Habit | Feasibility (Total Uses) | 23.7 mean uses of the app | Standard Deviation 19 |
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.
Time frame: 8-week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Weight Loss + Habit | Problem Solving Inventory | -.64 Total score | Standard Deviation 8.31 |
p-value: 0.6395% CI: [-3.34, 2.05]t-test, 2 sided
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.
Time frame: 16-week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Weight Loss + Habit | Social Problem Solving Inventory | -.76 Total score | Standard Deviation 13.07 |
p-value: 0.7395% CI: [-5.11, 3.6]t-test, 2 sided
Secondary
% Weight Change
Measured in pounds with a digital scale
Time frame: 8-week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Weight Loss + Habit | % Weight Change | -1.9 percentage of pounds | Standard Deviation 3 |
p-value: <0.00195% CI: [-0.0285, -0.0096]t-test, 2 sided
Secondary
% Weight Change
Measured in pounds with a digital scale
Time frame: 16 week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Weight Loss + Habit | % Weight Change | -1.67 percentage of pounds | Standard Deviation 7.3 |
p-value: 0.14395% CI: [-0.039, 0.006]t-test, 2 sided