Trial Outcomes & Findings for The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups (NCT NCT03700736)

NCT ID: NCT03700736

Last Updated: 2021-11-23

Results Overview

Recruitment rates will be calculated from the number of patients approached, screened, consented, and randomized.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 62 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2021-11-23

Participant Flow

Participant milestones

Measure	Facebook 6-month post-partum weight loss intervention delivered via a private Facebook group	Traditional 6-month post-partum weight loss intervention delivered via in-person group meetings
Overall Study STARTED	30	32
Overall Study COMPLETED	27	25
Overall Study NOT COMPLETED	3	7

Reasons for withdrawal

Measure	Facebook 6-month post-partum weight loss intervention delivered via a private Facebook group	Traditional 6-month post-partum weight loss intervention delivered via in-person group meetings
Overall Study Pregnancy	1	1
Overall Study Withdrawal by Subject	2	6

Baseline Characteristics

The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups

Baseline characteristics by cohort

Measure	Facebook n=30 Participants 6-month post-partum weight loss intervention delivered via a private Facebook group	Traditional n=32 Participants 6-month post-partum weight loss intervention delivered via in-person group meetings	Total n=62 Participants Total of all reporting groups
Age, Continuous	33.3 years STANDARD_DEVIATION 3.5 • n=5 Participants	32.3 years STANDARD_DEVIATION 4.4 • n=7 Participants	32.8 years STANDARD_DEVIATION 4.0 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	32 Participants n=7 Participants	62 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	26 Participants n=7 Participants	52 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	32 participants n=7 Participants	62 participants n=5 Participants
Weight	188.9 pounds n=5 Participants	180.6 pounds n=7 Participants	186.0 pounds n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Recruitment rates will be calculated from the number of patients approached, screened, consented, and randomized.

Outcome measures

Measure	Individuals Contacted n=606 Participants Individuals who expressed interest in study participation	Traditional 6-month post-partum weight loss intervention delivered via in-person group meetings
Recruitment Could not reach to screen	163 Participants	—
Recruitment Not interested in participating	105 Participants	—
Recruitment Ineligible at initial eligibility screening	195 Participants	—
Recruitment Eligible but did not complete baseline visit	65 Participants	—
Recruitment Eligible at screening but met additional exclusion criteria or did not complete baseline procedures	16 Participants	—
Recruitment Randomized	62 Participants	—

PRIMARY outcome

Timeframe: 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)

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.

Outcome measures

Measure	Individuals Contacted n=30 Participants Individuals who expressed interest in study participation	Traditional n=32 Participants 6-month post-partum weight loss intervention delivered via in-person group meetings
Sustained Participation	20 latest treatment module participated in Interval 19.0 to 20.0	18 latest treatment module participated in Interval 2.0 to 20.0

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Individuals Contacted n=26 Participants Individuals who expressed interest in study participation	Traditional n=28 Participants 6-month post-partum weight loss intervention delivered via in-person group meetings
Contamination Used other weight loss programs & sought weight loss info/support on social media	1 Participants	1 Participants
Contamination Used other weight loss programs	3 Participants	0 Participants
Contamination Sought weight loss info or support on social media	8 Participants	15 Participants
Contamination Neither	14 Participants	12 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Retention is defined as completing 6-month follow-up study assessment (providing weight and/or completing the follow-up survey)

Retention is calculated as the percentage of participants who complete the 6-month follow-up study assessment in each condition.

Outcome measures

Measure	Individuals Contacted n=30 Participants Individuals who expressed interest in study participation	Traditional n=32 Participants 6-month post-partum weight loss intervention delivered via in-person group meetings
Retention Retained	27 Participants	30 Participants
Retention Lost to follow-up	3 Participants	2 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Retention is defined as completing 12-month follow-up study assessment (providing weight and/or completing the follow-up survey)

Retention is calculated as the percentage of participants who complete the 12-month follow-up study assessment in each condition.

Outcome measures

Measure	Individuals Contacted n=30 Participants Individuals who expressed interest in study participation	Traditional n=32 Participants 6-month post-partum weight loss intervention delivered via in-person group meetings
Retention Retained	28 Participants	30 Participants
Retention Lost to follow-up	2 Participants	2 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Missing (or incomplete) measures needed for cost-effectiveness aim of subsequent efficacy trial: weight and/or quality of life measure.

Percent of participants missing data on each measure/item included in data collection at baseline.

Outcome measures

Measure	Individuals Contacted n=30 Participants Individuals who expressed interest in study participation	Traditional n=32 Participants 6-month post-partum weight loss intervention delivered via in-person group meetings
Degree of Missingness in Study Measures Missing (or incomplete) quality of life	4 Participants	2 Participants
Degree of Missingness in Study Measures Available information on both weight and quality of life	26 Participants	30 Participants

PRIMARY outcome

Timeframe: 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.

Percent of participants missing data on each measure/item included in data collection at 6 months.

Outcome measures

Measure	Individuals Contacted n=30 Participants Individuals who expressed interest in study participation	Traditional n=32 Participants 6-month post-partum weight loss intervention delivered via in-person group meetings
Degree of Missingness in Study Measures Missing weight and quality of life	3 Participants	2 Participants
Degree of Missingness in Study Measures Missing quality of life	1 Participants	3 Participants
Degree of Missingness in Study Measures Available information on both weight and quality of life	26 Participants	27 Participants

PRIMARY outcome

Timeframe: 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.

Percent of participants missing data on each measure/item included in data collection at 12 months.

Outcome measures

Measure	Individuals Contacted n=30 Participants Individuals who expressed interest in study participation	Traditional n=32 Participants 6-month post-partum weight loss intervention delivered via in-person group meetings
Degree of Missingness in Study Measures Missing weight and quality of life	2 Participants	2 Participants
Degree of Missingness in Study Measures Missing quality of life	0 Participants	1 Participants
Degree of Missingness in Study Measures Available information for both weight and quality of life	28 Participants	29 Participants

SECONDARY outcome

Timeframe: 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.

Weight will be measured at baseline and 6 months. Percent weight change will be calculated.

Outcome measures

Measure	Individuals Contacted n=27 Participants Individuals who expressed interest in study participation	Traditional n=30 Participants 6-month post-partum weight loss intervention delivered via in-person group meetings
Weight Change (Exploratory)	-3.0 percent weight loss from baseline Standard Deviation 7.2	-5.4 percent weight loss from baseline Standard Deviation 6.8

SECONDARY outcome

Timeframe: 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.

Weight will be measured at baseline and 12 months. Percent weight change will be calculated.

Outcome measures

Measure	Individuals Contacted n=28 Participants Individuals who expressed interest in study participation	Traditional n=30 Participants 6-month post-partum weight loss intervention delivered via in-person group meetings
Weight Change (Exploratory)	-2.8 percent weight loss from baseline Standard Deviation 7.4	-4.8 percent weight loss from baseline Standard Deviation 7.6

Adverse Events

Facebook

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Traditional

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Facebook n=30 participants at risk 6-month behavioral weight loss intervention delivered via a private Facebook group	Traditional n=32 participants at risk 6-month behavioral weight loss intervention delivered via in-person group meetings
General disorders Communicable disease (e.g., cold, flu)	50.0% 15/30 • Number of events 17 • Adverse events were collected during the intervention and at 6-month and 12-month follow-up assessments Adverse events were spontaneous reported by participants during the intervention and at follow-up assessments. Depressive symptoms and pregnancy were queried at the 6-month and 12-month assessments.	46.9% 15/32 • Number of events 17 • Adverse events were collected during the intervention and at 6-month and 12-month follow-up assessments Adverse events were spontaneous reported by participants during the intervention and at follow-up assessments. Depressive symptoms and pregnancy were queried at the 6-month and 12-month assessments.
General disorders 5% or greater weight gain	6.7% 2/30 • Number of events 2 • Adverse events were collected during the intervention and at 6-month and 12-month follow-up assessments Adverse events were spontaneous reported by participants during the intervention and at follow-up assessments. Depressive symptoms and pregnancy were queried at the 6-month and 12-month assessments.	9.4% 3/32 • Number of events 3 • Adverse events were collected during the intervention and at 6-month and 12-month follow-up assessments Adverse events were spontaneous reported by participants during the intervention and at follow-up assessments. Depressive symptoms and pregnancy were queried at the 6-month and 12-month assessments.
Injury, poisoning and procedural complications Musculoskeletal pain or injury (not related to exercise)	16.7% 5/30 • Number of events 5 • Adverse events were collected during the intervention and at 6-month and 12-month follow-up assessments Adverse events were spontaneous reported by participants during the intervention and at follow-up assessments. Depressive symptoms and pregnancy were queried at the 6-month and 12-month assessments.	12.5% 4/32 • Number of events 5 • Adverse events were collected during the intervention and at 6-month and 12-month follow-up assessments Adverse events were spontaneous reported by participants during the intervention and at follow-up assessments. Depressive symptoms and pregnancy were queried at the 6-month and 12-month assessments.
Pregnancy, puerperium and perinatal conditions Pregnancy during intervention or follow-up	6.7% 2/30 • Number of events 2 • Adverse events were collected during the intervention and at 6-month and 12-month follow-up assessments Adverse events were spontaneous reported by participants during the intervention and at follow-up assessments. Depressive symptoms and pregnancy were queried at the 6-month and 12-month assessments.	9.4% 3/32 • Number of events 3 • Adverse events were collected during the intervention and at 6-month and 12-month follow-up assessments Adverse events were spontaneous reported by participants during the intervention and at follow-up assessments. Depressive symptoms and pregnancy were queried at the 6-month and 12-month assessments.
Psychiatric disorders Depressive symptoms	40.0% 12/30 • Number of events 13 • Adverse events were collected during the intervention and at 6-month and 12-month follow-up assessments Adverse events were spontaneous reported by participants during the intervention and at follow-up assessments. Depressive symptoms and pregnancy were queried at the 6-month and 12-month assessments.	15.6% 5/32 • Number of events 6 • Adverse events were collected during the intervention and at 6-month and 12-month follow-up assessments Adverse events were spontaneous reported by participants during the intervention and at follow-up assessments. Depressive symptoms and pregnancy were queried at the 6-month and 12-month assessments.

Additional Information

Dr. Molly Waring

University of Connecticut

Phone: 860-486-1446

Email: molly.waring@uconn.edu

Results disclosure agreements

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