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.
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
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.
- Conditions
- Gestational Weight Gain
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Average weight
Measured: 12 week post-baseline
Secondary outcomes (3)
Depression
Edinburgh Postnatal Depression Scale (EPDS); scale: 1-30 with higher score indicating higher depression
Measured: 12 weeks post-baseline
Anxiety
General Anxiety Disorder- 7 scale (GAD-7); 1-7 scale with higher score indicating higher anxiety
Measured: 12 weeks post baseline
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.
- First posted3 Mar 2020
- Study start1 Sep 2020
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gestational Weight GainStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Jenn Leiferman, PhD, Principal investigator, University of Colorado, Denver
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My Baby My Move A Community Wellness Intervention
- ClinicalTrials.gov ID
- NCT04294095
- Acronym / sponsor ID
- MBMM+ / 19-1366
- Conditions
- Gestational Weight Gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Posted 21 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial (control and intervention)
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: My Baby My Move +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. |
| Control | Active comparator | Other: ControlElectronic 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. |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- -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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| My Baby My Move +This is a community-based, peer-led 12-week wellness intervention to decrease excessive gestational weight gain. | Other | Intervention |
| ControlThis is a 12-week basic prenatal education class. | Other | Control |
Primary outcome
Weight
Time frame: 12 week post-baseline
Average weight
3 secondary outcomes
Depression
Time frame: 12 weeks post-baseline
Anxiety
Time frame: 12 weeks post baseline
Physical Activity
Time frame: 12 weeks Post-baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No IPD will be shared with other researchers
Related trials for Gestational Weight Gain
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An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
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Mother and Offspring's Nutritional Status -Pregnancy After Maternal Bariatric Surgery
Bariatric Surgery, Pregnency
Active, not recruiting
Time-restricted Eating Among Pregnant Females With Severe Obesity
Obesity, Morbid, Time Restricted Eating
Recruiting
Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study
Pregnancies at Increased Risk for Excessive Gestational Weight Gain, Ecological Momentary Assessment and Intervention
Not yet recruiting
Healthy Adaptation to Pregnancy, Postpartum and Parenthood
Perinatal Mental Health, Gestational Weight Gain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenn Leiferman, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
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.