Diet Modification, Physical Activity, Weight Loss
Conditions
Keywords
post-partum women, social media, Facebook, digital health
Brief summary
The goal of the project is to conduct a feasibility pilot randomized trial comparing delivery of a post-partum weight loss intervention via Facebook versus via in-person group sessions. The project will provide preliminary data needed to finalize the design of a large randomized trial to compare the non-inferiority and cost-effectiveness of the post-partum weight loss intervention delivered via Facebook versus in-person group sessions. If efficacious and cost-effective, the Facebook-delivered intervention leads naturally to strategies for scaling up for widespread impact.
Detailed description
Post-partum weight retention contributes to obesity for many women, increasing risk for cardiovascular disease and other chronic diseases and complicating future pregnancies. Lifestyle interventions have shown to be modestly efficacious for post-partum weight loss in randomized controlled trials, yet interventions with numerous visits are logistically challenging for many post-partum women. Innovative and efficacious treatment models for post-partum weight loss that fit into the busy lives of new moms are needed, and cost-effectiveness is critical for adoption. Facebook may be an efficient platform for delivering evidence-based weight loss programming to post-partum women. Delivering interventions via Facebook allows us to connect with post-partum women where they are, more fully integrating into their lives and daily routines. Investigators have developed a post-partum weight loss intervention based on the Diabetes Prevention Program, tailored to needs of post-partum women and for delivery via Facebook. Investigators will conduct a feasibility pilot randomized trial comparing delivery of a post-partum weight loss intervention via Facebook to in-person group sessions. Primary outcomes are the feasibility of recruitment, sustained participation, contamination, retention, and feasibility of assessment procedures in both treatment conditions. Weight loss will be described as an exploratory outcome. The project will provide preliminary data needed to finalize the design of a large randomized trial to compare the non-inferiority and cost-effectiveness of the post-partum weight loss intervention delivered via Facebook versus in-person group sessions. Demonstrating cost-effectiveness in addition to efficacy of our Facebook-delivered post-partum weight loss intervention is critical to support widespread implementation.
Interventions
BEHAVIORALHealthy Moms
The 6-month intervention will include dietary and exercise counseling and tips to help participants meet their healthy lifestyle goals. Participants will receive personalized calorie and physical activity goals to help them achieve a healthy weight loss of 1-2 pounds per week. Participants will be encouraged to increase physical activity to 150 minutes per week of moderate intensity activity. Counselors will encourage and support participants to make a plan for incorporating regular physical activity into their lives in a way (i.e., duration per session, frequency per week) that works for that individual woman. We will encourage participants to track their diet and exercise daily. We will encourage participants to use My Fitness Pal to track their diet and activity.
Sponsors
University of Massachusetts, Worcester
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
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* women 18 years or older * 8 weeks to 12 months post-partum at enrollment * overweight or obese (BMI ≥ 25 kg/m2) per measured height and weight at the baseline visit * owns a scale * comfortable reading and speaking in English * owns an iPhone or Android smartphone * active Facebook user * medical clearance (e.g., from primary care provider or obstetrician/gynecologist) * willing and able to participate in either treatment condition (Facebook or in-person) * available to attend in-person meetings over the 6-month study period * 45 minutes or less to travel to intervention meetings * willing and able to provide informed consent
Exclusion criteria
* UConn employee or student who is key personnel on the study, UConn employee or student who is a spouse, dependent, or relative of any key personnel, or UConn student who key personnel on this study teaches * women who are currently pregnant or plan to conceive during study period * current participation in clinical weight loss program * Type 1 or Type 2 diabetes * medical conditions affecting weight * medications affecting weight * incapable of walking 1/4 of a mile without stopping * pain that prevents engagement in exercise * previous bariatric surgery * planned surgery during study period * plans to move out of the area during the study period * high depressive symptoms or suicidal ideation * positive screen for binge eating disorder * failure to complete the baseline survey * failure to complete the orientation webinar
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | Baseline | Recruitment rates will be calculated from the number of patients approached, screened, consented, and randomized. |
| Sustained Participation | 6 months | We will calculate sustained participation as time to last intervention session attended in the in-person condition and as time to last post, comment, or reaction (based on date of last post or comment reacted to) in the Facebook condition. |
| Contamination | 6 months | Participants in both treatment conditions will report if they have participated in other weight loss programs (online or in-person), and whether they have searched for weight loss support on Facebook or other online social networks. |
| Retention | 6 months | Retention is calculated as the percentage of participants who complete the 6-month follow-up study assessment in each condition. |
| Degree of Missingness in Study Measures | Baseline | Percent of participants missing data on each measure/item included in data collection at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change (Exploratory) | 6 months | Weight will be measured at baseline and 6 months. Percent weight change will be calculated. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Facebook 6-month post-partum weight loss intervention delivered via a private Facebook group | 30 |
| Traditional 6-month post-partum weight loss intervention delivered via in-person group meetings | 32 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Pregnancy | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 6 |
Baseline characteristics
| Characteristic | Total | Traditional | |
|---|---|---|---|
| Age, Continuous | 33.3 years STANDARD_DEVIATION 3.5 | 32.8 years STANDARD_DEVIATION 4 | 32.3 years STANDARD_DEVIATION 4.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 9 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 53 Participants | 28 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 | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 26 Participants | 52 Participants | 26 Participants |
| Region of Enrollment United States | 30 participants | 62 participants | 32 participants |
| Sex: Female, Male Female | 30 Participants | 62 Participants | 32 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Weight | 188.9 pounds | 186.0 pounds | 180.6 pounds |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 32 |
| other Total, other adverse events | 25 / 30 | 23 / 32 |
| serious Total, serious adverse events | 0 / 30 | 0 / 32 |
Outcome results
Primary
Contamination
Participants in both treatment conditions will report if they have participated in other weight loss programs (online or in-person), and whether they have searched for weight loss support on Facebook or other online social networks.
Time frame: 6 months
Population: Participants reported use of other weight loss programs and seeking weight loss info/support on social media on the 6-month survey. We report the number and percentage of participants in each condition that reported use of other weight loss programs, sought weight loss info/support on social media, both, or neither. These data are available only for participants who completed the 6-month survey. Note that we encouraged participants in both groups to reference online resources (e.g., recipes).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Individuals Contacted | Contamination | Used other weight loss programs & sought weight loss info/support on social media | 1 Participants |
| Individuals Contacted | Contamination | Used other weight loss programs | 3 Participants |
| Individuals Contacted | Contamination | Sought weight loss info or support on social media | 8 Participants |
| Individuals Contacted | Contamination | Neither | 14 Participants |
| Traditional | Contamination | Neither | 12 Participants |
| Traditional | Contamination | Used other weight loss programs & sought weight loss info/support on social media | 1 Participants |
| Traditional | Contamination | Sought weight loss info or support on social media | 15 Participants |
| Traditional | Contamination | Used other weight loss programs | 0 Participants |
Primary
Degree of Missingness in Study Measures
Percent of participants missing data on each measure/item included in data collection at baseline.
Time frame: Baseline
Population: Missing (or incomplete) measures needed for cost-effectiveness aim of subsequent efficacy trial: weight and/or quality of life measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Individuals Contacted | Degree of Missingness in Study Measures | Missing (or incomplete) quality of life | 4 Participants |
| Individuals Contacted | Degree of Missingness in Study Measures | Available information on both weight and quality of life | 26 Participants |
| Traditional | Degree of Missingness in Study Measures | Missing (or incomplete) quality of life | 2 Participants |
| Traditional | Degree of Missingness in Study Measures | Available information on both weight and quality of life | 30 Participants |
Primary
Degree of Missingness in Study Measures
Percent of participants missing data on each measure/item included in data collection at 12 months.
Time frame: 12 months
Population: Missing (or incomplete) measures needed for cost-effectiveness aim of subsequent efficacy trial: weight and/or quality of life measure. Note that as quality of measure was assessed as part of 12-month survey, participants who did not complete the survey are missing this measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Individuals Contacted | Degree of Missingness in Study Measures | Missing weight and quality of life | 2 Participants |
| Individuals Contacted | Degree of Missingness in Study Measures | Missing quality of life | 0 Participants |
| Individuals Contacted | Degree of Missingness in Study Measures | Available information for both weight and quality of life | 28 Participants |
| Traditional | Degree of Missingness in Study Measures | Missing weight and quality of life | 2 Participants |
| Traditional | Degree of Missingness in Study Measures | Missing quality of life | 1 Participants |
| Traditional | Degree of Missingness in Study Measures | Available information for both weight and quality of life | 29 Participants |
Primary
Degree of Missingness in Study Measures
Percent of participants missing data on each measure/item included in data collection at 6 months.
Time frame: 6 months
Population: Missing (or incomplete) measures needed for cost-effectiveness aim of subsequent efficacy trial: weight and/or quality of life measure. Note that as quality of measure was assessed as part of 6-month survey, participants who did not complete the survey are missing this measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Individuals Contacted | Degree of Missingness in Study Measures | Missing weight and quality of life | 3 Participants |
| Individuals Contacted | Degree of Missingness in Study Measures | Missing quality of life | 1 Participants |
| Individuals Contacted | Degree of Missingness in Study Measures | Available information on both weight and quality of life | 26 Participants |
| Traditional | Degree of Missingness in Study Measures | Missing weight and quality of life | 2 Participants |
| Traditional | Degree of Missingness in Study Measures | Missing quality of life | 3 Participants |
| Traditional | Degree of Missingness in Study Measures | Available information on both weight and quality of life | 27 Participants |
Primary
Recruitment
Recruitment rates will be calculated from the number of patients approached, screened, consented, and randomized.
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Individuals Contacted | Recruitment | Could not reach to screen | 163 Participants |
| Individuals Contacted | Recruitment | Not interested in participating | 105 Participants |
| Individuals Contacted | Recruitment | Ineligible at initial eligibility screening | 195 Participants |
| Individuals Contacted | Recruitment | Eligible but did not complete baseline visit | 65 Participants |
| Individuals Contacted | Recruitment | Eligible at screening but met additional exclusion criteria or did not complete baseline procedures | 16 Participants |
| Individuals Contacted | Recruitment | Randomized | 62 Participants |
Primary
Retention
Retention is calculated as the percentage of participants who complete the 12-month follow-up study assessment in each condition.
Time frame: 12 months
Population: Retention is defined as completing 12-month follow-up study assessment (providing weight and/or completing the follow-up survey)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Individuals Contacted | Retention | Retained | 28 Participants |
| Individuals Contacted | Retention | Lost to follow-up | 2 Participants |
| Traditional | Retention | Retained | 30 Participants |
| Traditional | Retention | Lost to follow-up | 2 Participants |
Primary
Retention
Retention is calculated as the percentage of participants who complete the 6-month follow-up study assessment in each condition.
Time frame: 6 months
Population: Retention is defined as completing 6-month follow-up study assessment (providing weight and/or completing the follow-up survey)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Individuals Contacted | Retention | Retained | 27 Participants |
| Individuals Contacted | Retention | Lost to follow-up | 3 Participants |
| Traditional | Retention | Retained | 30 Participants |
| Traditional | Retention | Lost to follow-up | 2 Participants |
Primary
Sustained Participation
We will calculate sustained participation as time to last intervention session attended in the in-person condition and as time to last post, comment, or reaction (based on date of last post or comment reacted to) in the Facebook condition.
Time frame: 6 months
Population: Latest treatment module participated in based on last intervention meeting attended (Traditional) or last treatment module engaged in based on original posts, replies/comments, reactions, and poll votes (Facebook)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Individuals Contacted | Sustained Participation | 20 latest treatment module participated in |
| Traditional | Sustained Participation | 18 latest treatment module participated in |
Secondary
Weight Change (Exploratory)
Weight will be measured at baseline and 6 months. Percent weight change will be calculated.
Time frame: 6 months
Population: Percent weight change from baseline to 6 months. All baseline weights were measured at a study visit. At 6 months, weight was measured at a study visit or participants self-reported current or pre-pregnancy weight (if pregnant). Note that due to COVID19, all follow-up weights for wave 2 were self-reported. Complete case weight change is reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individuals Contacted | Weight Change (Exploratory) | -3.0 percent weight loss from baseline | Standard Deviation 7.2 |
| Traditional | Weight Change (Exploratory) | -5.4 percent weight loss from baseline | Standard Deviation 6.8 |
Secondary
Weight Change (Exploratory)
Weight will be measured at baseline and 12 months. Percent weight change will be calculated.
Time frame: 12 months
Population: Percent weight change from baseline to 12 months. All baseline weights were measured at study visit. At 12 months, weight was measured at study visit or participants self-reported current or pre-pregnancy weight (if pregnant). Note that due to COVID19, all follow-up weights for wave 2 were self-reported. Complete case weight change is reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individuals Contacted | Weight Change (Exploratory) | -2.8 percent weight loss from baseline | Standard Deviation 7.4 |
| Traditional | Weight Change (Exploratory) | -4.8 percent weight loss from baseline | Standard Deviation 7.6 |