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

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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

Tracking Information
First Submitted Date  ICMJE March 13, 2019
First Posted Date  ICMJE March 19, 2019
Last Update Posted Date November 12, 2020
Actual Study Start Date  ICMJE October 1, 2020
Estimated Primary Completion Date July 14, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
  • Total gestational weight gain (GWG) [ Time Frame: From 10 gestational weeks until delivery (approximately 40 gestational weeks) ]
  • Rate of total GWG [ Time Frame: From 10 gestational weeks until delivery (approximately 40 gestational weeks) ]
  • Proportion of women meeting the Institute of Medicine's GWG recommendation [ Time Frame: From 10 gestational weeks until delivery (approximately 40 gestational weeks) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2019)
  • Trimester-specific weekly rate of GWG [ Time Frame: 0 - 13 gestational weeks; 14 - 26 gestational weeks; 27 - 40 gestational weeks ]
  • GWG trajectory throughout pregnancy [ Time Frame: From 10 gestational weeks until delivery (approximately 40 gestational weeks) ]
  • 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.
  • 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.
  • Postpartum weight retention [ Time Frame: Assessed at 6 weeks postpartum ]
  • 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 ]
  • Infant growth (BMI z-score) [ Time Frame: From birth to 6 months of age ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
  • Trimester-specific weekly rate of GWG [ Time Frame: 0 - 13 gestational weeks; 14 - 26 gestational weeks; 27 - 40 gestational weeks ]
  • GWG trajectory throughout pregnancy [ Time Frame: From 10 gestational weeks until delivery (approximately 40 gestational weeks) ]
  • 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 ]
    Change in moderate to vigorous physical activity between study assessments in pregnancy
  • 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.
  • Postpartum weight retention [ Time Frame: Assessed at 6 weeks postpartum ]
  • 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 ]
  • Infant growth (BMI z-score) [ Time Frame: From birth to 6 months of age ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women
Official Title  ICMJE Cluster Randomized Trial of a Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Gestational Weight Gain
Intervention  ICMJE Behavioral: Lifestyle Intervention
Behavioral lifestyle intervention
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Lifestyle Intervention
  • No Intervention: Usual Care - Control
    Usual Medical Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 15, 2019)
2040
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 28, 2024
Estimated Primary Completion Date July 14, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: This study is only enrolling female participants.
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Monique M Hedderson, Ph.D. (510) 891-3580 Monique.M.Hedderson@kp.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03880461
Other Study ID Numbers  ICMJE 1352535-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kaiser Permanente
Study Sponsor  ICMJE Kaiser Permanente
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE Not Provided
PRS Account Kaiser Permanente
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP