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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle Intervention | Experimental | 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 Care - Control | No Intervention | Usual Medical Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Intervention | Behavioral | Behavioral lifestyle intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Gestational Weight Gain (GWG) | Calculated as last measured pregnancy weight at the time of delivery minus measured weight at 10 gestational weeks | From 10 gestational weeks until time of delivery (duration of up to 9 months) |
| Rate of Total GWG | Calculated as total gestational weight gain / (# of weeks between 10 gestational weeks and the time of delivery) | From 10 gestational weeks until time of delivery (duration of up to 9 months) |
| 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 | From 10 gestational weeks until time of delivery (duration of up to 9 months) |
| 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 time of delivery (duration of up to 9 months) |
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Inclusion Criteria:
Exclusion Criteria:
This study is only enrolling female participants.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Oakland | Oakland | California | 94612 | United States | ||
| Kaiser Permanente Redwood City |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39710337 | Background | Sridhar SB, Ferrara A, Brown SD, Quesenberry CP, Xu F, Liu E, Sedgwick T, Kissel P, Serrato Bandera HD, Albright C, Hedderson MM. Protocol of an adaptive mobile health intervention for the management of gestational weight gain: The LEAP cluster randomized controlled trial. Contemp Clin Trials. 2025 Feb;149:107781. doi: 10.1016/j.cct.2024.107781. Epub 2024 Dec 20. | |
| 42008264 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Usual Care Arm - PATIENTS | Patients in the usual care arm will receive the standard obstetric care offered at Kaiser Permanente Northern California. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Gestational Weight Gain (GWG) | Calculated as last measured pregnancy weight at the time of delivery minus measured weight at 10 gestational weeks | Posted | Mean | Standard Deviation | kilograms | From 10 gestational weeks until time of delivery (duration of up to 9 months) |
|
Adverse outcome data were collected during pregnancy from enrollment to delivery (duration of up to 9 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Total pregnancy loss or stillbirth | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Monique Hedderson, Ph.D. | Kaiser Permanente Northern California | 925-520-0785 | monique.m.hedderson@kp.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 26, 2025 | Mar 26, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000078064 | Gestational Weight Gain |
| D001835 | Body Weight |
| D050177 | Overweight |
| D009765 | Obesity |
| D012816 | Signs and Symptoms |
| D001836 | Body Weight Changes |
| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| 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 12 months of age |
| Redwood City |
| California |
| 94063 |
| United States |
| Kaiser Permanente San Francisco | San Francisco | California | 94115 | United States |
| Kaiser Permanente Santa Clara | Santa Clara | California | 95051 | United States |
| Hedderson MM, Brown SD, Quesenberry CP, Xu F, Liu EF, Li KL, Sridhar SB, Sedgwick T, Kissel P, Bandera HDS, Bhalala MM, Albright CL, Ferrara A. Adaptive Mobile Health Intervention to Reduce Excess Gestational Weight Gain: A Cluster-Randomized Clinical Trial. JAMA Netw Open. 2026 Apr 1;9(4):e268007. doi: 10.1001/jamanetworkopen.2026.8007. |
| BG001 |
| Usual Care Arm - PATIENTS |
Patients in the usual care arm will receive the standard obstetric care offered at Kaiser Permanente Northern California. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pre-pregnancy BMI (Continuous) | Mean | Standard Deviation | kg/m2 |
|
| Pre-pregnancy BMI (Customized) | Count of Participants | Participants |
|
| Parity (Customized) | Count of Participants | Participants |
|
|
|
|
| Primary | Rate of Total GWG | Calculated as total gestational weight gain / (# of weeks between 10 gestational weeks and the time of delivery) | Posted | Mean | Standard Deviation | kilograms/week | From 10 gestational weeks until time of delivery (duration of up to 9 months) |
|
|
|
|
| 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 | Posted | Count of Participants | Participants | From 10 gestational weeks until time of delivery (duration of up to 9 months) |
|
|
|
|
| Secondary | Trimester-specific Weekly Rate of GWG | Not Posted | 0 - 13 gestational weeks; 14 - 26 gestational weeks; 27 - 40 gestational weeks | Participants |
| Secondary | GWG Trajectory Throughout Pregnancy | Not Posted | From 10 gestational weeks until time of delivery (duration of up to 9 months) | Participants |
| 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. | Not Posted | Between 12 weeks and 33 weeks of pregnancy | Participants |
| 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. | Not Posted | Assessed at 12 weeks of pregnancy | Participants |
| Secondary | Postpartum Weight Retention | Not Posted | Assessed at 6 weeks postpartum | Participants |
| Secondary | The Proportion of Infants With Appropriate Birthweight (>10th and <90th Percentile of Sex-, Gestational Age-, and Racial/Ethnic-specific Distribution) | Not Posted | Assessed at birth | Participants |
| Secondary | Infant Growth (BMI Z-score) | Not Posted | From birth to 12 months of age | Participants |
| 0 |
| 714 |
| 0 |
| 714 |
| 44 |
| 714 |
| EG001 | Usual Care Arm - PATIENTS | Patients in the usual care arm will receive the standard obstetric care offered at Kaiser Permanente Northern California. | 0 | 621 | 0 | 621 | 29 | 621 |
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| D009750 | Nutritional and Metabolic Diseases |