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Gestational Weight GainMBMM+NCT04294095

My Baby My Move A Community Wellness Intervention

A study testing My Baby My Move + in people with Gestational Weight Gain, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 46 years, women only
Conditions the study is for
Gestational Weight Gain
What is being tested?
My Baby My Move +
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteUnited States
Study dates
1 Sep 2020to 1 Jan 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 46 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • -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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Colorado Anschutz Campus

    Aurora, Colorado, 80045

Other trials in United States

About this study

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.

Read the detailed description

Intervention Group:

The MBMM+ intervention is designed to promote the engagement in physical activity and takes into account barriers among pregnant women cited in our formative work such as lack of knowledge and skills, body changes and discomfort, feeling limited, and lack of social support. Uniquely, the MBMM+ program also targets sleep hygiene and mood to further support regular physical activity engagement. Over the years of working with pregnant women, we have observed that once women notice how their regular physical activity helps their mood and sleep patterns they are often more likely to continue engaging in regular physical activity. During the first four weeks of the MBMM+ program, participants will receive electronic informational handouts covering topics on weight management (content will be based in part on Co-I Downs' Healthy Mom Zone intervention such as informing on benefits and guidelines of healthy GWG, tips on healthy eating, energy balance, and sleep quality) 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. Given that pregnant women often express a lack of knowledge about safe physical activities during pregnancy, preventing them from engaging in physical activity, each session will include both didactic and experiential components to increase knowledge and skill building. Sessions will begin with a didactic component covering overcoming barriers to physical activity, goal setting, self-monitoring, problem solving, topics related to mood (stress management, family/work balance, wellness wheel), sleep hygiene (setting routines, avoiding stimulants, environmental supports), and additional physical activity topics (e.g., managing physical activity in postpartum, overcoming relapses). Participants will be given educational materials in print and electronic form based on their preferences. The experiential component (i.e., physical activity) will be 30 minutes in duration and involve primarily walking, at a moderate intensity, based on national recommendations coupled with yoga. Our formative work suggests that mothers prefer walking and find it more enjoyable in the form of groups. We have chosen to also include yoga to provide options for ways to be active that also positively impact sleep and mood and pregnant women report desiring prenatal yoga. All walking sessions will be facilitated by the peer leaders. The yoga sessions will be taught by an experienced prenatal yoga instructor residing in Denver, CO.

Each session will have 3-4 peer leaders to help facilitate and model the physical activity component (i.e., will accompany women during their walking and yoga sessions to provide support and ensure safety (e.g., correct postures during yoga, monitoring exercise intensity and symptoms during walking sessions). Our MBMM formative work and expertise in community-based physical activity interventions suggests participants prefer peer group leaders because they foster a sense of community and social support within the group setting. Peer leaders will be compensated for their time working with the MBMM+ program and will be peer mothers from the community who are recent mothers (< two years postpartum) who successfully engaged in regular physical activity during a previous pregnancy. Peer leaders will be identified by our research team, recreation center directors, and health care provider partners. At the end of every session, participants will check in with an assigned peer leader to discuss in small groups their weekly logs. Peer leaders will note the discussions that occurred amongst the participants in their group, describe barriers that were identified, problem-solving strategies that were suggested and used, and future goals/recommended action steps. This group work will help participants to learn ways to fit physical activity into their lifestyle and overcome barriers by receiving feedback from their peer leader and other group members. It will also ensure that the intervention is conducted and received in the way intended as the peer leaders and program manager/PI will review these small group progress notes each week and monitor intervention delivery.

Peer leader training and fidelity: Weekly, the research team (PI/program manager) will have phone calls and/or in-person meetings with the group peer leaders to debrief and address any issues that may arise. The program manager and/or PI will be on-site for all sessions to ensure quality control of intervention delivery and data collection efforts by peer leaders. The PI will conduct a training session before the onset of the intervention with the peer group leaders to cover topics including how to engage in safe and effective physical activity during pregnancy, an overview of behavioral change theory and the behavioral skills that the intervention is targeting, ways to garner social support and leadership skills. The PI has been extensively trained by the Cooper Institute in Prenatal-Postnatal Physical Activity. The yoga instructor will have been extensively trained in prenatal yoga.

Control Group:

Women randomized to the control group will complete a similarly structured 12-week program; 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. Sessions will be held on weekday evenings and weekend mornings as these times were preferred by pregnant women.

Being tested
My Baby My Move +, Control
Medical subject headings
Gestational Weight Gain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • My Baby My Move +Other

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

  • ControlOther

    This is a 12-week basic prenatal education class.

Study groups in NCT04294095
Study groupRoleWhat they receive
InterventionExperimentalDuring 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.
Receives: Other: My Baby My Move +
ControlActive comparatorElectronic 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.
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight

    Average weight

    Measured: 12 week post-baseline

Secondary outcomes (3)
  1. Depression

    Edinburgh Postnatal Depression Scale (EPDS); scale: 1-30 with higher score indicating higher depression

    Measured: 12 weeks post-baseline

  2. Anxiety

    General Anxiety Disorder- 7 scale (GAD-7); 1-7 scale with higher score indicating higher anxiety

    Measured: 12 weeks post baseline

  3. Physical Activity

    The Godin-Shephard Leisure-Time Physical Activity Questionnaire (LTEQ) assesses when someone engages in mild, moderate, and vigorous exercise for more than 15 minutes within one week. The leisure activity score is calculated using the following formula: leisure activity score = (9 x strenuous activity per week) + (5 x moderate activity per week) + (3 x light activity per week). Strenuous exercise is defined as heart beating rapidly, moderate exercise is defined as not exhausting, and light activity is described as minimal effort. Scores of 14 or less indicate insufficiently active/sedentary, scores of 14-23 indicate moderately active, and scores of more than 24 indicate active.

    Measured: 12 weeks Post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2020
  2. Study start1 Sep 2020
  3. Primary completion1 Jan 2022
  4. Study completion1 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial (control and intervention)
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04294095
Sponsor's protocol ID
19-1366
Other IDs
1R21HD097450-01A1
Acronym
MBMM+
Status last verified
Mar 2023
First submitted
23 Jan 2020
Last updated
21 Mar 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD will be shared with other researchers

Questions about this trial

What is this clinical trial studying?

A study testing My Baby My Move + in people with Gestational Weight Gain, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight (time frame: 12 week post-baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.

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