An interventional study of Healthy Moms in Weight Loss, Diet Modification and Physical Activity, sponsored by University of Connecticut. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-23.
Sponsored by University of Connecticut · Not applicable, Interventional, and Other
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.
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.
1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.
This study's enrollment of 62 is close to the median of 64 across 947 interventional studies indexed under Body Weight.
Browse Body Weight studies →University of Connecticut is the lead sponsor of 133 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Women will receive the Healthy Moms intervention, a 6-month behavioral weight loss intervention, via a private ("secret") Facebook group. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based lifestyle intervention. A study counselor will facilitate discussions about the topics posted in the Facebook group. Each participant will get an individualized calorie and physical activity goal 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. Participants will also be encouraged to download the MyFitnessPal app to track daily diet.
Behavioral: Healthy Moms
Women will receive the Healthy Moms intervention, a 6-month behavioral weight loss intervention, via in-person 90-minute group sessions (weekly in months 1-4, every other week in months 5-6). The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based lifestyle intervention. Intervention components will be introduced in the format of handouts, group discussions, and lists of existing resources. Each participant will get an individualized calorie and physical activity goal 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. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet.
Behavioral: Healthy 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.
Recruitment
Recruitment rates will be calculated from the number of patients approached, screened, consented, and randomized.
Time frame: Baseline
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
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
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
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
Degree of Missingness in Study Measures
Percent of participants missing data on each measure/item included in data collection at baseline.
Time frame: Baseline
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
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
Weight Change (Exploratory)
Weight will be measured at baseline and 6 months. Percent weight change will be calculated.
Time frame: 6 months
Weight Change (Exploratory)
Weight will be measured at baseline and 12 months. Percent weight change will be calculated.
Time frame: 12 months
| Milestone | Traditional | |
|---|---|---|
| Started | 30 | 32 |
| Completed | 27 | 25 |
| Not completed | 3 | 7 |
| Withdrew: Pregnancy | 1 | 1 |
| Withdrew: Withdrawal by subject | 2 | 6 |
Recruitment rates will be calculated from the number of patients approached, screened, consented, and randomized.
| Participants | Individuals Contacted |
|---|---|
| Could not reach to screen | 163 |
| Not interested in participating | 105 |
| Ineligible at initial eligibility screening | 195 |
| Eligible but did not complete baseline visit | 65 |
| Eligible at screening but met additional exclusion criteria or did not complete baseline procedures | 16 |
| Randomized | 62 |
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.
| latest treatment module participated in | Traditional | |
|---|---|---|
| Sustained Participation | 20 (19 to 20) | 18 (2 to 20) |
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.
| Participants | Traditional | |
|---|---|---|
| Used other weight loss programs & sought weight loss info/support on social media | 1 | 1 |
| Used other weight loss programs | 3 | 0 |
| Sought weight loss info or support on social media | 8 | 15 |
| Neither | 14 | 12 |
Retention is calculated as the percentage of participants who complete the 6-month follow-up study assessment in each condition.
| Participants | Traditional | |
|---|---|---|
| Retained | 27 | 30 |
| Lost to follow-up | 3 | 2 |
Retention is calculated as the percentage of participants who complete the 12-month follow-up study assessment in each condition.
| Participants | Traditional | |
|---|---|---|
| Retained | 28 | 30 |
| Lost to follow-up | 2 | 2 |
Percent of participants missing data on each measure/item included in data collection at baseline.
| Participants | Traditional | |
|---|---|---|
| Missing (or incomplete) quality of life | 4 | 2 |
| Available information on both weight and quality of life | 26 | 30 |
Percent of participants missing data on each measure/item included in data collection at 6 months.
| Participants | Traditional | |
|---|---|---|
| Missing weight and quality of life | 3 | 2 |
| Missing quality of life | 1 | 3 |
| Available information on both weight and quality of life | 26 | 27 |
Percent of participants missing data on each measure/item included in data collection at 12 months.
| Participants | Traditional | |
|---|---|---|
| Missing weight and quality of life | 2 | 2 |
| Missing quality of life | 0 | 1 |
| Available information for both weight and quality of life | 28 | 29 |
Weight will be measured at baseline and 6 months. Percent weight change will be calculated.
| percent weight loss from baseline | Traditional | |
|---|---|---|
| Weight Change (Exploratory) | -3.0 ± 7.2 | -5.4 ± 6.8 |
Weight will be measured at baseline and 12 months. Percent weight change will be calculated.
| percent weight loss from baseline | Traditional | |
|---|---|---|
| Weight Change (Exploratory) | -2.8 ± 7.4 | -4.8 ± 7.6 |
Collected over Adverse events were collected during the intervention and at 6-month and 12-month follow-up assessments. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 0/30 (0%) | 0/30 (0%) | 25/30 (83.3%) | |
| Traditional | 0/32 (0%) | 0/32 (0%) | 23/32 (71.9%) |
| Event | Traditional | |
|---|---|---|
| Communicable disease (e.g., cold, flu)General disorders | 15/30 | 15/32 |
| Depressive symptomsPsychiatric disorders | 12/30 | 5/32 |
| Musculoskeletal pain or injury (not related to exercise)Injury, poisoning and procedural complications | 5/30 | 4/32 |
| 5% or greater weight gainGeneral disorders | 2/30 | 3/32 |
| Pregnancy during intervention or follow-upPregnancy, puerperium and perinatal conditions | 2/30 | 3/32 |
| Age, Continuous(years) | Traditional | Total | |
|---|---|---|---|
| Mean | 33.3 ± 3.5 | 32.3 ± 4.4 | 32.8 ± 4.0 |
| Sex: Female, Male(Participants) | Traditional | Total | |
|---|---|---|---|
| Female | 30 | 32 | 62 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Traditional | Total | |
|---|---|---|---|
| Hispanic or Latino | 5 | 4 | 9 |
| Not Hispanic or Latino | 25 | 28 | 53 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Traditional | Total | |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 3 | 4 |
| White | 26 | 26 | 52 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(participants) | Traditional | Total | |
|---|---|---|---|
| United States | 30 | 32 | 62 |
| Weight(pounds) | Traditional | Total | |
|---|---|---|---|
| Median | 188.9 (171.0 to 225.3) | 180.6 (168.6 to 214.6) | 186.0 (169.2 to 217.1) |
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