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A Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03880461
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : November 12, 2020
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Kaiser Permanente

Study Description
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Brief Summary:
The aim of this trial is to investigate the effectiveness of a mobile health (mhealth) intervention to help overweight and obese women achieve appropriate gestational weight gain (GWG) for their pre-pregnancy body mass index (BMI). The goal of the intervention is to help women achieve GWG within the range recommended by the Institute of Medicine. The investigators propose an adaptive intervention that begins with an effective, yet low resource-intensive treatment and then provides incremental support and resources only to patients who need them. The intervention includes: 1) an mHealth tools allowing data to be automatically transmitted to a mobile website; 2) personalized text messages; and 3) personalized 1:1 telephone coaching sessions. The latter more intensive components are reserved for patients whose GWG is not within the IOM guidelines. The lifestyle intervention will be delivered through 1 telephone counseling session with a study dietician trained in motivational interviewing techniques, as well as through technology-based tools, automated text messages and weekly e-mails of core lifestyle intervention sessions. Personalized text messages and 1:1 telephone coaching sessions will be given to those who are not meeting the GWG guidelines. The lifestyle intervention will be compared to usual medical care. Maternal outcomes will be assessed shortly before delivery and at 6 weeks postpartum. Infant birthweight and weight at one year will also be assessed.

Condition or disease Intervention/treatment Phase
Gestational Weight Gain Behavioral: Lifestyle Intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2040 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cluster Randomized Trial of a Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : July 14, 2023
Estimated Study Completion Date : June 28, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lifestyle Intervention
The goal of the intervention is to help women achieve GWG within the range recommended by the Institute of Medicine. The lifestyle intervention will be delivered through 1 telephone counseling session with a study dietician trained in motivational interviewing techniques, as well as through technology-based tools, automated text messages and weekly e-mails of core lifestyle intervention sessions. Personalized text messages and 1:1 telephone coaching sessions will be given to those who are not meeting the GWG guidelines.
 Behavioral: Lifestyle Intervention
Behavioral lifestyle intervention
No Intervention: Usual Care - Control
Usual Medical Care


Outcome Measures
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Primary Outcome Measures :
  1. Total gestational weight gain (GWG) [ Time Frame: From 10 gestational weeks until delivery (approximately 40 gestational weeks) ]
  2. Rate of total GWG [ Time Frame: From 10 gestational weeks until delivery (approximately 40 gestational weeks) ]
  3. Proportion of women meeting the Institute of Medicine's GWG recommendation [ Time Frame: From 10 gestational weeks until delivery (approximately 40 gestational weeks) ]

Secondary Outcome Measures :
  1. Trimester-specific weekly rate of GWG [ Time Frame: 0 - 13 gestational weeks; 14 - 26 gestational weeks; 27 - 40 gestational weeks ]
  2. GWG trajectory throughout pregnancy [ Time Frame: From 10 gestational weeks until delivery (approximately 40 gestational weeks) ]
  3. Change in moderate to vigorous physical activity (in MET hrs/week) as assessed by the Pregnancy Physical Activity Questionnaire (PPAQ) [ Time Frame: Between 12 weeks and 33 weeks of pregnancy ]
    We will assess change in moderate to vigorous physical activity between study assessments in pregnancy. The sports and exercise domain encompasses 10 PPAQ activities of moderate intensity (ranging 3.2 MET to 6 MET) and 2 PPAQ activities of vigorous intensity (6.5 MET and 7 MET). The volumes of all activities in the sports and exercise domain will be summed to arrive at an estimate of overall volume of moderate to vigorous intensity sports and exercise activity, expressed in MET hours per week. Higher levels of activity are generally associated with better outcomes. The distributions of all physical activity variables will be assessed for outliers.

  4. Overall diet quality according to the Healthy Eating Index-2015 (HEI-2015) [ Time Frame: Assessed at 12 weeks of pregnancy ]
    The HEI-2015 reflects adherence to the 2015-2020 Dietary Guidelines for Americans; it is comprised of 13 components as well as an overall score. The scoring system ranges from 0 to 100, where higher values indicate a better diet quality.

  5. Postpartum weight retention [ Time Frame: Assessed at 6 weeks postpartum ]
  6. The proportion of infants with appropriate birthweight (>10th and <90th percentile of sex-, gestational age-, and racial/ethnic-specific distribution) [ Time Frame: Assessed at birth ]
  7. Infant growth (BMI z-score) [ Time Frame: From birth to 6 months of age ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study is only enrolling female participants.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant
  • Women receiving prenatal care at Kaiser Permanente San Francisco and Oakland and whose obstetric care clinicians consent to participate;
  • Pregravid BMI 25 to <40 (as determined from a measured pregravid weight in electronic medical record);
  • Has access to a smartphone and Wi-Fi;
  • Provides informed consent to participate.

Exclusion Criteria:

  • Multiple births;
  • Planning to move out of the area during the study period;
  • Inability to speak, read, or understand English;
  • Placed on bed rest at time of enrollment; ->15 weeks' gestation at enrollment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880461


Contacts
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Contact: Monique M Hedderson, Ph.D. (510) 891-3580 Monique.M.Hedderson@kp.org

Locations
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United States, California
Kaiser Permanente Oakland Recruiting
Oakland, California, United States, 94612
Kaiser Permanente San Francisco Recruiting
San Francisco, California, United States, 94115
Sponsors and Collaborators
Kaiser Permanente
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
More Information
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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT03880461    
Other Study ID Numbers: 1352535-1
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaiser Permanente:
Gestational weight gain
Lifestyle
Intervention
Body weight
 Overweight
Obesity
Signs and Symptoms
Body weight changes
Additional relevant MeSH terms:
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Body Weight
Overweight
Weight Gain
Gestational Weight Gain
Body Weight Changes