search
Back to results

Healthy Motivations for Moms-to-be Study (HM2B)

Primary Purpose

Weight Gain, Pregnancy, Stress, Emotional

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Eating and Physical Activity
Stress Reduction and Management
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Weight Gain focused on measuring Pregnancy, Weight, Gestational weight gain, Stress reduction, Exercise

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Pregnant upon enrollment
  • Singleton pregnancy
  • 20-35 years old
  • Current resident of the United States
  • Valid email address to receive study updates
  • Owner of an Android or iPhone and willing to download a commercially-available, free mobile app

Exclusion Criteria:

  • Does not own or cannot access a scale to weigh themselves regularly
  • Has uncontrolled/untreated thyroid disease
  • Currently takes insulin for diabetes
  • Has high blood pressure that is not controlled
  • Has had persistent bleeding in the first trimester
  • Has a history of 3 or more miscarriages
  • Has a history of incompetent (weakened) cervix
  • Currently has or has ever had an eating disorder or malnutrition
  • Has physical disabilities that prevent her from exercising
  • Was told by her doctor that she should NOT exercise during pregnancy

Sites / Locations

  • University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Healthy Eating/Physical Activity (HEPA)

Stress Reduction/Management (SRAM)

Arm Description

The goals of the HEPA condition are to encourage healthy eating and physical activity behaviors for gaining a healthy amount of weight during pregnancy and to provide motivation and social support to help overcome challenges to eating healthier and becoming more physically active while pregnant. 12 weeks of group-based health behavior (nutrition/PA focused) challenges and weight tracking; podcasts (10); weekly pregnancy tips website and mobile app

The goals of the SRAM condition are to encourage stress reduction and management techniques as well as to provide motivation and social support to reduce stress levels during pregnancy. 12 weeks of group-based health behavior (stress reduction/management) challenges and weight tracking; podcasts (10); weekly pregnancy tips website and mobile app

Outcomes

Primary Outcome Measures

Total gestational weight gain (kg)
Photo-verified scale displays at baseline (<20 weeks), 32 weeks, and delivery (40 weeks)

Secondary Outcome Measures

Social engagement within group-based challenges
Total engagement score will be computed for app and website usage
Podcast listenership
Number of podcasts downloaded by individual participant
Motivation to change behavior
Surveys administered at baseline (<20 weeks) and 32 weeks

Full Information

First Posted
January 17, 2017
Last Updated
March 14, 2018
Sponsor
University of South Carolina
search

1. Study Identification

Unique Protocol Identification Number
NCT03063528
Brief Title
Healthy Motivations for Moms-to-be Study
Acronym
HM2B
Official Title
Healthy Motivations for Moms-to-be Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 5, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
March 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Carolina

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This proposal is part of a broader research agenda that posits healthy gestational weight gain (GWG) may be achieved through behavioral intervention and may potentially reduce adverse maternal and infant health outcomes associated with excessive weight gain during pregnancy. The purpose of this study is to examine the use of a mobile application (mobile app) and mobile website for encouraging and maintaining healthy behaviors such as healthy eating, regular exercise, and stress management and reduction during pregnancy. The study will include collaborative group-based health behavior challenges for pregnant women living in the United States. The study will test the effectiveness of the intervention on improving maternal health behaviors. The proposed research project will examine if an intervention targeting healthy eating and exercise leads to significantly less weight gained during pregnancy versus a comparison group that receives stress reduction and management content.
Detailed Description
The purpose of this study is to test the effects of a mobile app and study website for a gestational weight gain intervention targeted to pregnant women living anywhere in the United States (n=130). Participants will be assigned to groups of 8-12 and assigned to two conditions: intervention or comparison. The intervention groups will receive a weight-related intervention (focused on fruit and vegetable intake, self-regulation of foods, and physical activity (PA)), while the comparison groups will receive a non-diet/PA health behavior program (focused on sleep, stress reduction, mental health, and stress management). Participants will be instructed on how to use the a commercially available free mobile app and study website. Each week for 12 consecutive weeks, participants will receive a health related behavioral goal through the mobile app. Participants can track their goal achievements through the app and connect with other pregnant women in the study. The study website will have participants log daily body weight or stress level, based on their respective group assignments. The study website will also offer 10 podcasts and weekly pregnancy tips related to the study content of both groups. Participants will also be asked to complete three online surveys and provide a report of body weight at three time points throughout pregnancy. Participants will receive an incentive gift for their participation. The proposed research project is significant for several reasons: (1) rates of overweight and obesity among pregnant and postpartum women are increasing, (2) overweight and obesity is associated with unfavorable maternal and child health outcomes and (3) past research has demonstrated the importance of providing social support during pregnancy to reduce antenatal and postpartum depression. The proposed research project is innovative for several reasons: (1) current modes of delivering interventions are costly and may be limited in reach and scope while mobile technology provides a solution to these burdens, (2) this intervention is the first of its kind to utilize a commercially-available mobile app to address GWG among pregnant women living in the US, (3) using mobile technology for all aspects of the study will allow greater reach to rural populations who have limited ability to regularly receive health information, and (4) this intervention will employ social support strategies by grouping pregnant women into small groups assigned with a weekly weight-related health goal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain, Pregnancy, Stress, Emotional, Exercise, Nutrition
Keywords
Pregnancy, Weight, Gestational weight gain, Stress reduction, Exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Eating/Physical Activity (HEPA)
Arm Type
Experimental
Arm Description
The goals of the HEPA condition are to encourage healthy eating and physical activity behaviors for gaining a healthy amount of weight during pregnancy and to provide motivation and social support to help overcome challenges to eating healthier and becoming more physically active while pregnant. 12 weeks of group-based health behavior (nutrition/PA focused) challenges and weight tracking; podcasts (10); weekly pregnancy tips website and mobile app
Arm Title
Stress Reduction/Management (SRAM)
Arm Type
Experimental
Arm Description
The goals of the SRAM condition are to encourage stress reduction and management techniques as well as to provide motivation and social support to reduce stress levels during pregnancy. 12 weeks of group-based health behavior (stress reduction/management) challenges and weight tracking; podcasts (10); weekly pregnancy tips website and mobile app
Intervention Type
Behavioral
Intervention Name(s)
Healthy Eating and Physical Activity
Other Intervention Name(s)
HEPA
Intervention Description
Participants will be assigned to a group of 8-10 other pregnant women to work towards the same healthy eating or physical activity behavior challenge each week for a total of 12 weeks. The challenges will not require travel or financial support, but will focus on modifying or encouraging daily lifestyle activities, such as "drink 8 full glasses of water 3 times this week." Participants will track their healthy eating and physical activity behaviors in a mobile app. The HEPA condition will have access to podcasts and informational tips for having a healthy pregnancy through the study website. The HEPA condition will be able to log their weight on a daily basis and track their overall weight gain on a chart through the study website.
Intervention Type
Behavioral
Intervention Name(s)
Stress Reduction and Management
Other Intervention Name(s)
SRAM
Intervention Description
Participants will be put into a group of 8-10 other pregnant women to work towards the same stress reduction and management goal each week for a total of 12 weeks. The challenges will not require travel or financial support, but will focus on modifying or encouraging daily lifestyle activities, such as "take a 15 minute technology break each day this week." Participants will track their stress reduction and management behaviors in a mobile app. In addition, the SRAM condition will have access to meditation podcasts and informational tips for having a healthy pregnancy through the study website. Lastly, the SRAM condition will be able to rate their stress level on a daily basis and track their stress on a graph.
Primary Outcome Measure Information:
Title
Total gestational weight gain (kg)
Description
Photo-verified scale displays at baseline (<20 weeks), 32 weeks, and delivery (40 weeks)
Time Frame
baseline (<20 weeks), 32 weeks, and delivery (40 weeks)
Secondary Outcome Measure Information:
Title
Social engagement within group-based challenges
Description
Total engagement score will be computed for app and website usage
Time Frame
12 weeks
Title
Podcast listenership
Description
Number of podcasts downloaded by individual participant
Time Frame
20-36 weeks
Title
Motivation to change behavior
Description
Surveys administered at baseline (<20 weeks) and 32 weeks
Time Frame
baseline (<20 weeks) and 32 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pregnant upon enrollment Singleton pregnancy 20-35 years old Current resident of the United States Valid email address to receive study updates Owner of an Android or iPhone and willing to download a commercially-available, free mobile app Exclusion Criteria: Does not own or cannot access a scale to weigh themselves regularly Has uncontrolled/untreated thyroid disease Currently takes insulin for diabetes Has high blood pressure that is not controlled Has had persistent bleeding in the first trimester Has a history of 3 or more miscarriages Has a history of incompetent (weakened) cervix Currently has or has ever had an eating disorder or malnutrition Has physical disabilities that prevent her from exercising Was told by her doctor that she should NOT exercise during pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alicia A Dahl, MS
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://brie.net
Description
Related Info

Learn more about this trial

Healthy Motivations for Moms-to-be Study

We'll reach out to this number within 24 hrs