Gestational Weight Gain
Conditions
Keywords
Gestational weight gain, Lifestyle, Intervention, Body weight, Overweight, Obesity, Signs and Symptoms, Body weight changes
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.
Interventions
BEHAVIORALLifestyle Intervention
Behavioral lifestyle intervention
Sponsors
Kaiser Permanente
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Gestational Weight Gain (GWG) | 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 |
| Rate of Total GWG | 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) |
| Proportion of Women Meeting the Institute of Medicine's GWG Recommendation | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 time of delivery (duration of up to 9 months) | — |
| Change in Moderate to Vigorous Physical Activity (in MET Hrs/Week) as Assessed by the Pregnancy Physical Activity Questionnaire (PPAQ) | 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) | 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 | 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 12 months of age | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm - PATIENTS In addition to usual medical care, patients in the intervention arm will receive access to mHealth tools to manage gestational weight gain (GWG), including a scale, physical activity tracker, and smartphone application, and for those not meeting GWG guidelines, personalized text messages and personalized 1-1 coaching sessions. | 714 |
| Usual Care Arm - PATIENTS Patients in the usual care arm will receive the standard obstetric care offered at Kaiser Permanente Northern California. | 621 |
| Total | 1,335 |
Baseline characteristics
| Characteristic | Intervention Arm - PATIENTS | Usual Care Arm - PATIENTS | Total |
|---|---|---|---|
| Age, Continuous | 33.3 years STANDARD_DEVIATION 4.7 | 33.4 years STANDARD_DEVIATION 4.5 | 33.4 years STANDARD_DEVIATION 4.6 |
| Age, Customized Age (years) 21 - 29 | 158 Participants | 122 Participants | 280 Participants |
| Age, Customized Age (years) 30 - 34 | 259 Participants | 238 Participants | 497 Participants |
| Age, Customized Age (years) 35 - 39 | 234 Participants | 215 Participants | 449 Participants |
| Age, Customized Age (years) 40 - 46 | 63 Participants | 46 Participants | 109 Participants |
| Parity (Customized) Multiparous | 103 Participants | 127 Participants | 230 Participants |
| Parity (Customized) Nulliparous | 319 Participants | 238 Participants | 557 Participants |
| Parity (Customized) Primiparous | 270 Participants | 239 Participants | 509 Participants |
| Parity (Customized) Unknown / Missing | 22 Participants | 17 Participants | 39 Participants |
| Pre-pregnancy BMI (Continuous) | 29.7 kg/m2 STANDARD_DEVIATION 3.8 | 30.0 kg/m2 STANDARD_DEVIATION 3.9 | 29.8 kg/m2 STANDARD_DEVIATION 3.8 |
| Pre-pregnancy BMI (Customized) Obese (30.0 - 39.9) | 284 Participants | 267 Participants | 551 Participants |
| Pre-pregnancy BMI (Customized) Overweight (25.0 - 29.9) | 430 Participants | 354 Participants | 784 Participants |
| Race/Ethnicity, Customized Race / Ethnicity Asian / Pacific Islander | 175 Participants | 137 Participants | 312 Participants |
| Race/Ethnicity, Customized Race / Ethnicity Black | 41 Participants | 40 Participants | 81 Participants |
| Race/Ethnicity, Customized Race / Ethnicity Hispanic | 186 Participants | 165 Participants | 351 Participants |
| Race/Ethnicity, Customized Race / Ethnicity Islander | 6 Participants | 4 Participants | 10 Participants |
| Race/Ethnicity, Customized Race / Ethnicity Multiracial | 37 Participants | 41 Participants | 78 Participants |
| Race/Ethnicity, Customized Race / Ethnicity Native American | 10 Participants | 4 Participants | 14 Participants |
| Race/Ethnicity, Customized Race / Ethnicity Non-Hispanic White | 237 Participants | 211 Participants | 448 Participants |
| Race/Ethnicity, Customized Race / Ethnicity Unknown / Missing | 22 Participants | 19 Participants | 41 Participants |
| Region of Enrollment United States | 714 participants | 621 participants | 1335 participants |
| Sex: Female, Male Female | 714 Participants | 621 Participants | 1335 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 714 | 0 / 621 |
| other Total, other adverse events | 44 / 714 | 29 / 621 |
| serious Total, serious adverse events | 0 / 714 | 0 / 621 |
Outcome results
Primary
Proportion of Women Meeting the Institute of Medicine's GWG Recommendation
Proportion of women meeting the IOM's GWG recommendation for weekly rate of GWG
Time frame: From 10 gestational weeks until time of delivery (duration of up to 9 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm - PATIENTS | Proportion of Women Meeting the Institute of Medicine's GWG Recommendation | 172 Participants |
| Usual Care Arm - PATIENTS | Proportion of Women Meeting the Institute of Medicine's GWG Recommendation | 126 Participants |
p-value: 0.108ANOVA
Primary
Rate of Total GWG
Calculated as total gestational weight gain / (# of weeks between 10 gestational weeks and the time of delivery)
Time frame: From 10 gestational weeks until time of delivery (duration of up to 9 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm - PATIENTS | Rate of Total GWG | 0.26 kilograms/week | Standard Deviation 0.17 |
| Usual Care Arm - PATIENTS | Rate of Total GWG | 0.28 kilograms/week | Standard Deviation 0.16 |
p-value: 0.003t-test, 2 sided
Primary
Total Gestational Weight Gain (GWG)
Calculated as last measured pregnancy weight at the time of delivery minus measured weight at 10 gestational weeks
Time frame: From 10 gestational weeks until time of delivery (duration of up to 9 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm - PATIENTS | Total Gestational Weight Gain (GWG) | 10.5 kilograms | Standard Deviation 5.7 |
| Usual Care Arm - PATIENTS | Total Gestational Weight Gain (GWG) | 11.3 kilograms | Standard Deviation 5.9 |
p-value: 0.014t-test, 2 sided
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.
Time frame: Between 12 weeks and 33 weeks of pregnancy
Secondary
GWG Trajectory Throughout Pregnancy
Time frame: From 10 gestational weeks until time of delivery (duration of up to 9 months)
Secondary
Infant Growth (BMI Z-score)
Time frame: From birth to 12 months of age
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.
Time frame: Assessed at 12 weeks of pregnancy
Secondary
Postpartum Weight Retention
Time frame: 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)
Time frame: Assessed at birth
Secondary
Trimester-specific Weekly Rate of GWG
Time frame: 0 - 13 gestational weeks; 14 - 26 gestational weeks; 27 - 40 gestational weeks