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

Primary Purpose

Gestational Weight Gain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Intervention
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Weight Gain focused on measuring Gestational weight gain, Lifestyle, Intervention, Body weight, Overweight, Obesity, Signs and Symptoms, Body weight changes

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Kaiser Permanente OaklandRecruiting
  • Kaiser Permanente San FranciscoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lifestyle Intervention

Usual Care - Control

Arm Description

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.

Usual Medical Care

Outcomes

Primary Outcome Measures

Total gestational weight gain (GWG)
Rate of total GWG
Proportion of women meeting the Institute of Medicine's GWG recommendation

Secondary Outcome Measures

Trimester-specific weekly rate of GWG
GWG trajectory throughout pregnancy
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.
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.
Postpartum weight retention
The proportion of infants with appropriate birthweight (>10th and <90th percentile of sex-, gestational age-, and racial/ethnic-specific distribution)
Infant growth (BMI z-score)

Full Information

First Posted
March 13, 2019
Last Updated
March 8, 2023
Sponsor
Kaiser Permanente
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03880461
Brief Title
A Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women
Official Title
Cluster Randomized Trial of a Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2021 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
November 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Weight Gain
Keywords
Gestational weight gain, Lifestyle, Intervention, Body weight, Overweight, Obesity, Signs and Symptoms, Body weight changes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2040 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care - Control
Arm Type
No Intervention
Arm Description
Usual Medical Care
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Intervention
Intervention Description
Behavioral lifestyle intervention
Primary Outcome Measure Information:
Title
Total gestational weight gain (GWG)
Time Frame
From 10 gestational weeks until delivery (approximately 40 gestational weeks)
Title
Rate of total GWG
Time Frame
From 10 gestational weeks until delivery (approximately 40 gestational weeks)
Title
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 Measure Information:
Title
Trimester-specific weekly rate of GWG
Time Frame
0 - 13 gestational weeks; 14 - 26 gestational weeks; 27 - 40 gestational weeks
Title
GWG trajectory throughout pregnancy
Time Frame
From 10 gestational weeks until delivery (approximately 40 gestational weeks)
Title
Change in moderate to vigorous physical activity (in MET hrs/week) as assessed by the Pregnancy Physical Activity Questionnaire (PPAQ)
Description
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.
Time Frame
Between 12 weeks and 33 weeks of pregnancy
Title
Overall diet quality according to the Healthy Eating Index-2015 (HEI-2015)
Description
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.
Time Frame
Assessed at 12 weeks of pregnancy
Title
Postpartum weight retention
Time Frame
Assessed at 6 weeks postpartum
Title
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
Title
Infant growth (BMI z-score)
Time Frame
From birth to 6 months of age

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
This study is only enrolling female participants.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monique M Hedderson, Ph.D.
Phone
(510) 891-3580
Email
Monique.M.Hedderson@kp.org
Facility Information:
Facility Name
Kaiser Permanente Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Individual Site Status
Recruiting
Facility Name
Kaiser Permanente San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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