My Baby My Move A Community Wellness Intervention

NCT04294095 | Completed Results DMC

• 2 other identifiers: 19-13661R21HD097450-01A1
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gestational Weight Gain

Outcome Measures

Primary Outcomes (1)

• Weight

  Average weight

  12 week post-baseline

Secondary Outcomes (3)

• Depression

  12 weeks post-baseline

• Anxiety

  12 weeks post baseline

• Physical Activity

  12 weeks Post-baseline

Study Arms (2)

Intervention

EXPERIMENTAL

During the first four weeks of the MBMM+ program, participants will receive electronic informational handouts covering topics on weight management as well as the benefits and safety concerns related to prenatal physical activity. Starting week 5 of the 12-week intervention, participants will attend two in-person, group physical activity sessions per week with each session lasting approximately 60 minutes and will be held at a local community center located close to the recruitment clinics. Sessions will be held on weekday evenings and weekend mornings as these times were preferred by pregnant women. Each session will include both didactic and experiential components to increase knowledge and skill building.

Other: My Baby My Move +

Control

ACTIVE COMPARATOR

Electronic materials related to various prenatal topics including preparation for birth, birthing options, and responsive parenting will be distributed twice a week for the first 4-weeks of the program. Starting week 5 of the 12-week intervention, participants will attend two in-person, group sessions per week with each session lasting approximately 60 minutes and will be held at a local community center located close to the recruitment clinics.

Other: Control

Interventions

My Baby My Move + OTHER

This is a community-based, peer-led 12-week wellness intervention to decrease excessive gestational weight gain.

Intervention

Control OTHER

This is a 12-week basic prenatal education class.

Control

Eligibility Criteria

• Age: 18 Years - 46 Years
• Gender Eligibility Details: Pregnant Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Colorado Anschutz Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Gestational Weight Gain

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The trial was limited due to the onset of the Covid pandemic and the inability to have direct contact with participants. The entire trial had to pivot from an in-person data collection and intervention delivery system to an online platform and limited objective data collection. Due to the special population of pregnant women and the associated high-risk of covid, we had challenges recruiting women as well as obtaining medical clearance forms from overburdened health care providers.

Results Point of Contact

• Title: Jenn Leiferman
• Organization: Colorado School of Public Health

jenn.leiferman@cuanschutz.edu

303-724-4386

Study Officials

• Jenn Leiferman, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial (control and intervention)

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: March 3, 2020
• Study Start: September 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: March 21, 2023
• Results First Posted: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)