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

Gestational Weight Gain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03880461
• Other study ID #: 1352535-1
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 21, 2021
• Est. completion date: November 15, 2024

Study information

• Verified date: April 2024
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1335
• Est. completion date: November 15, 2024
• Est. primary completion date: February 22, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Gestational Weight Gain
• Overweight
• Weight Gain

Intervention

Behavioral:
• Lifestyle Intervention
Behavioral lifestyle intervention

Locations

Country	Name	City	State
United States	Kaiser Permanente Oakland	Oakland	California
United States	Kaiser Permanente San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total gestational weight gain (GWG)		From 10 gestational weeks until delivery (approximately 40 gestational weeks)
Primary	Rate of total GWG		From 10 gestational weeks until delivery (approximately 40 gestational weeks)
Primary	Proportion of women meeting the Institute of Medicine's GWG recommendation		From 10 gestational weeks until delivery (approximately 40 gestational weeks)
Secondary	Trimester-specific weekly rate of GWG		0 - 13 gestational weeks; 14 - 26 gestational weeks; 27 - 40 gestational weeks
Secondary	GWG trajectory throughout pregnancy		From 10 gestational weeks until delivery (approximately 40 gestational weeks)
Secondary	Change in moderate to vigorous physical activity (in MET hrs/week) as assessed by the Pregnancy Physical Activity Questionnaire (PPAQ)	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.	Between 12 weeks and 33 weeks of pregnancy
Secondary	Overall diet quality according to the Healthy Eating Index-2015 (HEI-2015)	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.	Assessed at 12 weeks of pregnancy
Secondary	Postpartum weight retention		Assessed at 6 weeks postpartum
Secondary	The proportion of infants with appropriate birthweight (>10th and <90th percentile of sex-, gestational age-, and racial/ethnic-specific distribution)		Assessed at birth
Secondary	Infant growth (BMI z-score)		From birth to 6 months of age