N/A
N=50
My Baby My Move A Community Wellness Intervention
Gestational Weight Gain
Bottom Line
View on ClinicalTrials.gov: NCT04294095 ↗Enrolled (actual)
50
Serious AEs
2.0%
Results posted
Mar 2023
Primary outcome: Primary: Weight — 162.9; 162.3 pounds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- My Baby My Move + (Other); Control (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight |
162.9; 162.3 | — |
| SECONDARY Depression |
8.1; 6.3 | — |
| SECONDARY Anxiety |
4.7; 3.7 | — |
| SECONDARY Physical Activity |
48.0; 35.9 | — |
Summary
My Baby, My Move+ (2019-2021) is a peer-led wellness intervention which aims to reduce excessive gestational weight gain (EGWG) by targeting prenatal physical activity, mood, and sleep quality. Up to 50% of pregnant women in the U.S. gain weight in excess of the Institute of Medicine guidelines. EGWG leads to poor maternal and child outcomes. It also sets the stage for long-term overweight/obesity for both mother and child. The MBMM+ intervention is an example of a theoretically-based prenatal physical activity intervention that targets these outcomes.
Up to 100 pregnant women (50 intervention arm, 50 control arm) will be recruited from the University of Colorado Clinics. Women in the intervention arm will participate in the 12-week MBMM+ intervention. Leiferman and her team propose to develop and test the feasibility and sustainability of the MBMM+ intervention to instill good healthy habits (e.g., prenatal physical activity, good sleep hygiene, stress management) during and beyond pregnancy. Findings from this study will be used to inform a future, large randomized trial.
Eligibility Criteria
Inclusion Criteria
- English-speaking
- pregnant (6-10 weeks) women
- aged 18-46 years
- reside in Denver, CO
- currently engaging in less than 120 minutes of moderate-intensity exercise per week
- have medical clearance to exercise during pregnancy.
Exclusion Criteria
-having conditions that preclude exercise (i.e. HCP has restricted patient from engaging in exercise according to AGOG's absolute contraindications to exercise (e.g. haemodynamically significant heart disease, restrictive lung disease, incompetent cervix/cerclage, persistent second or third trimester bleeding, placenta previa after 26 weeks gestation, premature labor during the current pregnancy, ruptured membranes, and pregnancy induced hypertension)
Data sourced from ClinicalTrials.gov (NCT04294095). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.