Trial Outcomes & Findings for A Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women (NCT NCT03880461)
NCT ID: NCT03880461
Last Updated: 2025-04-18
Results Overview
Calculated as last measured pregnancy weight at the time of delivery minus measured weight at 10 gestational weeks
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1335 participants
Primary outcome timeframe
From 10 gestational weeks until time of delivery (duration of up to 9 months)
Results posted on
2025-04-18
Participant Flow
Participant milestones
| Measure |
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.
|
Usual Care Arm - PATIENTS
Patients in the usual care arm will receive the standard obstetric care offered at Kaiser Permanente Northern California.
|
|---|---|---|
|
Overall Study
STARTED
|
714
|
621
|
|
Overall Study
COMPLETED
|
645
|
560
|
|
Overall Study
NOT COMPLETED
|
69
|
61
|
Reasons for withdrawal
| Measure |
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.
|
Usual Care Arm - PATIENTS
Patients in the usual care arm will receive the standard obstetric care offered at Kaiser Permanente Northern California.
|
|---|---|---|
|
Overall Study
Determined ineligible after enrollment
|
45
|
44
|
|
Overall Study
No weight measurement after enrollment
|
24
|
17
|
Baseline Characteristics
A Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women
Baseline characteristics by cohort
| Measure |
Intervention Arm - PATIENTS
n=714 Participants
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.
|
Usual Care Arm - PATIENTS
n=621 Participants
Patients in the usual care arm will receive the standard obstetric care offered at Kaiser Permanente Northern California.
|
Total
n=1335 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.3 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
33.4 years
STANDARD_DEVIATION 4.5 • n=7 Participants
|
33.4 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
Age, Customized
Age (years) · 21 - 29
|
158 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Age, Customized
Age (years) · 30 - 34
|
259 Participants
n=5 Participants
|
238 Participants
n=7 Participants
|
497 Participants
n=5 Participants
|
|
Age, Customized
Age (years) · 35 - 39
|
234 Participants
n=5 Participants
|
215 Participants
n=7 Participants
|
449 Participants
n=5 Participants
|
|
Age, Customized
Age (years) · 40 - 46
|
63 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
714 Participants
n=5 Participants
|
621 Participants
n=7 Participants
|
1335 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · Non-Hispanic White
|
237 Participants
n=5 Participants
|
211 Participants
n=7 Participants
|
448 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · Black
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · Asian / Pacific Islander
|
175 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
312 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · Hispanic
|
186 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
351 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · Native American
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · Islander
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · Multiracial
|
37 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · Unknown / Missing
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
714 participants
n=5 Participants
|
621 participants
n=7 Participants
|
1335 participants
n=5 Participants
|
|
Pre-pregnancy BMI (Continuous)
|
29.7 kg/m2
STANDARD_DEVIATION 3.8 • n=5 Participants
|
30.0 kg/m2
STANDARD_DEVIATION 3.9 • n=7 Participants
|
29.8 kg/m2
STANDARD_DEVIATION 3.8 • n=5 Participants
|
|
Pre-pregnancy BMI (Customized)
Overweight (25.0 - 29.9)
|
430 Participants
n=5 Participants
|
354 Participants
n=7 Participants
|
784 Participants
n=5 Participants
|
|
Pre-pregnancy BMI (Customized)
Obese (30.0 - 39.9)
|
284 Participants
n=5 Participants
|
267 Participants
n=7 Participants
|
551 Participants
n=5 Participants
|
|
Parity (Customized)
Nulliparous
|
319 Participants
n=5 Participants
|
238 Participants
n=7 Participants
|
557 Participants
n=5 Participants
|
|
Parity (Customized)
Primiparous
|
270 Participants
n=5 Participants
|
239 Participants
n=7 Participants
|
509 Participants
n=5 Participants
|
|
Parity (Customized)
Multiparous
|
103 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
230 Participants
n=5 Participants
|
|
Parity (Customized)
Unknown / Missing
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Intervention Arm - PATIENTS
n=591 Participants
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.
|
Usual Care Arm - PATIENTS
n=520 Participants
Patients in the usual care arm will receive the standard obstetric care offered at Kaiser Permanente Northern California.
|
|---|---|---|
|
Total Gestational Weight Gain (GWG)
|
10.5 kilograms
Standard Deviation 5.7
|
11.3 kilograms
Standard Deviation 5.9
|
PRIMARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Intervention Arm - PATIENTS
n=645 Participants
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.
|
Usual Care Arm - PATIENTS
n=560 Participants
Patients in the usual care arm will receive the standard obstetric care offered at Kaiser Permanente Northern California.
|
|---|---|---|
|
Rate of Total GWG
|
0.26 kilograms/week
Standard Deviation 0.17
|
0.28 kilograms/week
Standard Deviation 0.16
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Intervention Arm - PATIENTS
n=645 Participants
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.
|
Usual Care Arm - PATIENTS
n=560 Participants
Patients in the usual care arm will receive the standard obstetric care offered at Kaiser Permanente Northern California.
|
|---|---|---|
|
Proportion of Women Meeting the Institute of Medicine's GWG Recommendation
|
172 Participants
|
126 Participants
|
SECONDARY outcome
Timeframe: 0 - 13 gestational weeks; 14 - 26 gestational weeks; 27 - 40 gestational weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From 10 gestational weeks until time of delivery (duration of up to 9 months)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Between 12 weeks and 33 weeks of pregnancyWe 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at 12 weeks of pregnancyThe 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at 6 weeks postpartumOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at birthOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From birth to 12 months of ageOutcome measures
Outcome data not reported
Adverse Events
Intervention Arm - PATIENTS
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
Usual Care Arm - PATIENTS
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Arm - PATIENTS
n=714 participants at risk
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.
|
Usual Care Arm - PATIENTS
n=621 participants at risk
Patients in the usual care arm will receive the standard obstetric care offered at Kaiser Permanente Northern California.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Total pregnancy loss or stillbirth
|
6.2%
44/714 • Adverse outcome data were collected during pregnancy from enrollment to delivery (duration of up to 9 months).
|
4.7%
29/621 • Adverse outcome data were collected during pregnancy from enrollment to delivery (duration of up to 9 months).
|
Additional Information
Monique Hedderson, Ph.D.
Kaiser Permanente Northern California
Phone: 925-520-0785
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place