An interventional study of Lifestyle Intervention in Gestational Weight Gain, sponsored by Kaiser Permanente. Completed at 4 sites in United States. Open to female participants aged 21 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Prevention
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.
134 studies on the registry are indexed under Gestational Weight Gain; 24 are open to participants now.
This study's enrollment of 1,335 is above the median of 104 across 108 interventional studies indexed under Gestational Weight Gain.
Browse Gestational Weight Gain studies →Kaiser Permanente is the lead sponsor of 393 studies on the registry; 43 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Usual Medical Care
Behavioral lifestyle intervention
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)
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)
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)
Trimester-specific Weekly Rate of GWG
Time frame: 0 - 13 gestational weeks; 14 - 26 gestational weeks; 27 - 40 gestational weeks
GWG Trajectory Throughout Pregnancy
Time frame: 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)
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
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
Postpartum Weight Retention
Time frame: 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)
Time frame: Assessed at birth
Infant Growth (BMI Z-score)
Time frame: From birth to 12 months of age
| Milestone | Intervention Arm - PATIENTS | Usual Care Arm - PATIENTS |
|---|---|---|
| Started | 714 | 621 |
| Completed | 645 | 560 |
| Not completed | 69 | 61 |
| Withdrew: Determined ineligible after enrollment | 45 | 44 |
| Withdrew: No weight measurement after enrollment | 24 | 17 |
Calculated as last measured pregnancy weight at the time of delivery minus measured weight at 10 gestational weeks
| kilograms | Intervention Arm - PATIENTS | Usual Care Arm - PATIENTS |
|---|---|---|
| Total Gestational Weight Gain (GWG) | 10.5 ± 5.7 | 11.3 ± 5.9 |
Calculated as total gestational weight gain / (# of weeks between 10 gestational weeks and the time of delivery)
| kilograms/week | Intervention Arm - PATIENTS | Usual Care Arm - PATIENTS |
|---|---|---|
| Rate of Total GWG | 0.26 ± 0.17 | 0.28 ± 0.16 |
Proportion of women meeting the IOM's GWG recommendation for weekly rate of GWG
| Participants | Intervention Arm - PATIENTS | Usual Care Arm - PATIENTS |
|---|---|---|
| Proportion of Women Meeting the Institute of Medicine's GWG Recommendation | 172 | 126 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over Adverse outcome data were collected during pregnancy from enrollment to delivery (duration of up to 9 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Arm - PATIENTS | 0/714 (0%) | 0/714 (0%) | 44/714 (6.2%) |
| Usual Care Arm - PATIENTS | 0/621 (0%) | 0/621 (0%) | 29/621 (4.7%) |
| Event | Intervention Arm - PATIENTS | Usual Care Arm - PATIENTS |
|---|---|---|
| Total pregnancy loss or stillbirthPregnancy, puerperium and perinatal conditions | 44/714 | 29/621 |
| Age, Continuous(years) | Intervention Arm - PATIENTS | Usual Care Arm - PATIENTS | Total |
|---|---|---|---|
| Mean | 33.3 ± 4.7 | 33.4 ± 4.5 | 33.4 ± 4.6 |
| Age, Customized(Participants) | Intervention Arm - PATIENTS | Usual Care Arm - PATIENTS | Total |
|---|---|---|---|
| Age (years) — 21 - 29 | 158 | 122 | 280 |
| Age (years) — 30 - 34 | 259 | 238 | 497 |
| Age (years) — 35 - 39 | 234 | 215 | 449 |
| Age (years) — 40 - 46 | 63 | 46 | 109 |
| Sex: Female, Male(Participants) | Intervention Arm - PATIENTS | Usual Care Arm - PATIENTS | Total |
|---|---|---|---|
| Female | 714 | 621 | 1335 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Intervention Arm - PATIENTS | Usual Care Arm - PATIENTS | Total |
|---|---|---|---|
| Race / Ethnicity — Non-Hispanic White | 237 | 211 | 448 |
| Race / Ethnicity — Black | 41 | 40 | 81 |
| Race / Ethnicity — Asian / Pacific Islander | 175 | 137 | 312 |
| Race / Ethnicity — Hispanic | 186 | 165 | 351 |
| Race / Ethnicity — Native American | 10 | 4 | 14 |
| Race / Ethnicity — Islander | 6 | 4 | 10 |
| Race / Ethnicity — Multiracial | 37 | 41 | 78 |
| Race / Ethnicity — Unknown / Missing | 22 | 19 | 41 |
| Region of Enrollment(participants) | Intervention Arm - PATIENTS | Usual Care Arm - PATIENTS | Total |
|---|---|---|---|
| United States | 714 | 621 | 1335 |
| Pre-pregnancy BMI (Continuous)(kg/m2) | Intervention Arm - PATIENTS | Usual Care Arm - PATIENTS | Total |
|---|---|---|---|
| Mean | 29.7 ± 3.8 | 30.0 ± 3.9 | 29.8 ± 3.8 |
| Pre-pregnancy BMI (Customized)(Participants) | Intervention Arm - PATIENTS | Usual Care Arm - PATIENTS | Total |
|---|---|---|---|
| Overweight (25.0 - 29.9) | 430 | 354 | 784 |
| Obese (30.0 - 39.9) | 284 | 267 | 551 |
| Parity (Customized)(Participants) | Intervention Arm - PATIENTS | Usual Care Arm - PATIENTS | Total |
|---|---|---|---|
| Nulliparous | 319 | 238 | 557 |
| Primiparous | 270 | 239 | 509 |
| Multiparous | 103 | 127 | 230 |
| Unknown / Missing | 22 | 17 | 39 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2021 to primary completion in Mar 2024, 38 months.
Results were first posted in Apr 2025, 1 year after primary completion.
Of 84 non-industry interventional studies with no phase under Gestational Weight Gain, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 38. This study's 38 months is above that.
Counting every sponsor, half of 84 studies reached it within 24 months; a quarter within 13 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.