Obesity
Conditions
Keywords
obesity, lifestyle intervention, mobile app
Brief summary
The purpose of this pilot trial is to evaluate the feasibility of a lifestyle intervention where participants will all receive online weight loss counseling delivered via a private Facebook group, but be randomized to the Habit app (developed by the investigators) or MyFitnessPal, a commercial calorie tracking app.
Detailed description
The purpose of this pilot trial is to evaluate the feasibility of a program where 70 adults with overweight or obesity will receive online weight loss counseling delivered via a private Facebook group, but be randomized to the Habit app (developed by the investigators) or MyFitnessPal, a commercial calorie tracking app. Participants randomized to the Habit app will be asked to record their weight daily, monitor their dietary temptations, plan their exercise, and solve diet and exercise related problems. The temptation tracker helps users identify triggers and track when and why those triggers lead to dietary lapses. The exercise planner allows users to plan their exercise for the week and track whether they completed or missed the exercise and why they missed it. The Habit app provides insights to users about the patterns of their dietary lapses and exercise habits. The problem solver feature helps users identify their biggest problem with diet/exercise and then asks a series of questions to help the app provide tailored solutions to the participant to work on. Participants randomized to MyFitnessPal will track their calorie intake and exercise daily during the intervention.
Interventions
BEHAVIORALBuilding Habits Together
Private, hidden Facebook group Building Habits Together includes 24 weeks on content based on the Diabetes Prevention Program and the Habit app.
BEHAVIORALGetting Healthy Together
Private, hidden Facebook group Getting Healthy Together includes 24 weeks on content based on the Diabetes Prevention Program and the MyFitnessPal app.
Sponsors
Worcester Polytechnic Institute
National Heart, Lung, and Blood Institute (NHLBI)
University of Connecticut
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 18-65 years old * Body mass index (BMI) 27-45 kg/m2 * Wi-Fi connectivity at home * Logs into Facebook at least 5 days per week over the past 2 weeks * Has posted/replied on Facebook at least once a week in the past 2 weeks * Able to participate in the study in English * Interested in losing weight
Exclusion criteria
* Under the age of 18 and over the age of 65 * BMI under 27 or over 45 at screening; then under 27 at the point of the first weight on scale * Does not have Wi-Fi connectivity at home * Does not have a Facebook account * Does not log into Facebook at least 5 days per week over the past 2 weeks * Did not post/reply on Facebook once a week over the past 2 weeks * Not able to participate in the study in English * Does not live in the United States * Not interested in losing weight * Pregnant/lactating or plans to become pregnant during study period * Reports having bipolar disorder, substance abuse, psychosis, an eating disorder, or severe depression * Had bariatric surgery or plans to have surgery during the study * Currently taking medication affecting weight * Has lost ≥5% of weight in past 3 months * Is participating or intends to participate in another weight loss program during the study that provides coaching or problem solving * Chronic pain that interferes with the ability to exercise * Has Type 1 Diabetes * Has Type 2 Diabetes * Unable to make dietary changes or increase physical activity * Unable to walk ¼ mile unaided without stopping * Currently smokes or vapes nicotine * No phone connectivity at home and work * Has a digestive disorder/condition that precludes dietary changes * Meets criteria for severe depression on the Patient Health Questionnaire (PHQ)-8 (score of \>19) * Does not currently own a smartphone * Smartphone type and/or version not meeting app requirements * Participated in previous weight loss studies under the PI * Unable to attend the orientation webinar * If University of Connecticut (UConn) employee/student has concerns about being in a Facebook group with other UConn faculty, staff, and students * Had major surgery in past 6 months and have not been cleared by their doctor to resume physical activity and diet changes * Plans to have major surgery in the next 6-months * Has an implanted cardiac defibrillator or pacemaker * Did not complete screening and on-board processes of study (screening survey, webinar, e-consent, baseline survey, app set-up, scale set-up, etc.) * Not willing to be audiotaped for focus groups * Prisoner; or * Unable to provide consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Engagement Per Participant in the Facebook Group | 24 weeks | For each participant, investigators will calculate total engagement in the Facebook group as defined as reactions (e.g., like, care, wow, etc.), replies, posts, and poll votes during the 24-week program. Then we will calculate mean or median engagement per participant over 24 weeks. |
| Mobile App Use | 24 weeks | Investigators will calculate the number of days participants used their assigned app |
| Retention | 24 weeks | Investigators will calculate retention as the proportion of participants who provide weight data at the 24 week follow-up |
| Time Consuming (Burden) | 24 weeks | Participants will rate their assigned app in terms of whether they felt it took too much time out of their day (% who strongly agree/agree) |
| Ease of Use (Acceptability) | 24 weeks | Participants will rate how easy it was to use their assigned app (% who strongly agree/agree) |
| Contamination | 24 weeks | Investigators will report the percent of participants in the Habit condition that used MyFitnessPal or other calorie tracking apps during the program. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Baseline Weight Lost at 24 Weeks | 24 weeks | Investigators will calculate percent weight change from baseline at 24 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Building Habits Together The Building Habits Together arm includes the 24-week, Facebook-delivered lifestyle intervention based on the Diabetes Prevention Program and use of the Habit app (temptation tracking, exercise planning, and problem solving features).
Building Habits Together: Private, hidden Facebook group Building Habits Together includes 24 weeks on content based on the Diabetes Prevention Program and the Habit app. | 35 |
| Getting Healthy Together The Getting Healthy Together arm includes the 24-week, Facebook-delivered lifestyle intervention based on the Diabetes Prevention Program and use of the MyFitnessPal app (daily calorie tracking, exercise tracking).
Getting Healthy Together: Private, hidden Facebook group Getting Healthy Together includes 24 weeks on content based on the Diabetes Prevention Program and the MyFitnessPal app. | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | Building Habits Together | Getting Healthy Together | Total |
|---|---|---|---|
| Age, Continuous | 43.1 years STANDARD_DEVIATION 12 | 46.4 years STANDARD_DEVIATION 11.4 | 44.7 years STANDARD_DEVIATION 11.7 |
| Body mass index | 33.5 kg/m^2 STANDARD_DEVIATION 5.1 | 34.4 kg/m^2 STANDARD_DEVIATION 5.1 | 33.9 kg/m^2 STANDARD_DEVIATION 5.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 2 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 33 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 13 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 16 Participants | 36 Participants |
| Sex/Gender, Customized Female | 26 Participants | 25 Participants | 51 Participants |
| Sex/Gender, Customized Male | 8 Participants | 9 Participants | 17 Participants |
| Sex/Gender, Customized Non-binary | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 1 / 35 | 0 / 35 |
Outcome results
Primary
Contamination
Investigators will report the percent of participants in the Habit condition that used MyFitnessPal or other calorie tracking apps during the program.
Time frame: 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Building Habits Together | Contamination | 0 Participants |
Primary
Ease of Use (Acceptability)
Participants will rate how easy it was to use their assigned app (% who strongly agree/agree)
Time frame: 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Building Habits Together | Ease of Use (Acceptability) | 18 Participants |
| Getting Healthy Together | Ease of Use (Acceptability) | 20 Participants |
Primary
Engagement Per Participant in the Facebook Group
For each participant, investigators will calculate total engagement in the Facebook group as defined as reactions (e.g., like, care, wow, etc.), replies, posts, and poll votes during the 24-week program. Then we will calculate mean or median engagement per participant over 24 weeks.
Time frame: 24 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Building Habits Together | Engagement Per Participant in the Facebook Group | 112 total reactions, replies, posts, votes |
| Getting Healthy Together | Engagement Per Participant in the Facebook Group | 96 total reactions, replies, posts, votes |
Primary
Mobile App Use
Investigators will calculate the number of days participants used their assigned app
Time frame: 24 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Building Habits Together | Mobile App Use | 18 days out of 168 total |
| Getting Healthy Together | Mobile App Use | 33 days out of 168 total |
Primary
Retention
Investigators will calculate retention as the proportion of participants who provide weight data at the 24 week follow-up
Time frame: 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Building Habits Together | Retention | 33 participants |
| Getting Healthy Together | Retention | 35 participants |
Primary
Time Consuming (Burden)
Participants will rate their assigned app in terms of whether they felt it took too much time out of their day (% who strongly agree/agree)
Time frame: 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Building Habits Together | Time Consuming (Burden) | 6 Participants |
| Getting Healthy Together | Time Consuming (Burden) | 8 Participants |
Secondary
Percentage of Baseline Weight Lost at 24 Weeks
Investigators will calculate percent weight change from baseline at 24 weeks
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Building Habits Together | Percentage of Baseline Weight Lost at 24 Weeks | 2.1 percent baseline weight lost | Standard Deviation 5.6 |
| Getting Healthy Together | Percentage of Baseline Weight Lost at 24 Weeks | 5 percent baseline weight lost | Standard Deviation 5.8 |