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Completed

NCT Number: NCT03880461

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

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 tool 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.

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Key information

Conditions

Gestational Weight Gain Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

21 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Oakland, Oakland, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lifestyle Intervention

Behavioral

Behavioral lifestyle intervention

Primary outcomes

  1. Total Gestational Weight Gain (GWG)

    Time frame: From 10 gestational weeks until time of delivery (duration of up to 9 months)

    Calculated as last measured pregnancy weight at the time of delivery minus measured weight at 10 gestational weeks

  2. Rate of Total GWG

    Time frame: From 10 gestational weeks until time of delivery (duration of up to 9 months)

    Calculated as total gestational weight gain / (# of weeks between 10 gestational weeks and the time of delivery)

  3. Proportion of Women Meeting the Institute of Medicine's GWG Recommendation

    Time frame: From 10 gestational weeks until time of delivery (duration of up to 9 months)

    Proportion of women meeting the IOM's GWG recommendation for weekly rate of GWG

Secondary outcomes

  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 time of delivery (duration of up to 9 months)

  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 12 months of age

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Cluster Randomized Trial of a Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Mar 19, 2019
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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