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

Study Overview
=================
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.

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

Conditions
-----------------
Gestational Weight Gain

Intervention / Treatment
-----------------
* Behavioral: Lifestyle Intervention


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle Intervention<br>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<br>* Behavioral lifestyle intervention<br>|
| No Intervention: Usual Care - Control<br>Usual Medical Care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total gestational weight gain (GWG) |  | From 10 gestational weeks until delivery (approximately 40 gestational weeks) | 
| Rate of total GWG |  | From 10 gestational weeks until delivery (approximately 40 gestational weeks) | 
| Proportion of women meeting the Institute of Medicine's GWG recommendation |  | From 10 gestational weeks until delivery (approximately 40 gestational weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trimester-specific weekly rate of GWG |  | 0 - 13 gestational weeks; 14 - 26 gestational weeks; 27 - 40 gestational weeks | 
| GWG trajectory throughout pregnancy |  | 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) | 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 | 
| 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 | 
| Postpartum weight retention |  | 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) |  | Assessed at birth | 
| Infant growth (BMI z-score) |  | From birth to 6 months of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gestational weight gain, Lifestyle, Intervention, Body weight, Overweight, Obesity, Signs and Symptoms, Body weight changes