Goals for Reaching Optimal Wellness: GROWell
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04449432|
Recruitment Status : Recruiting
First Posted : June 26, 2020
Last Update Posted : April 27, 2022
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Related Gestational Weight Gain Postpartum Weight Retention Overweight and Obesity||Behavioral: GROWell (Interactive Obesity Treatment Approach) Behavioral: Attention Support Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||480 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Comparing intervention to active control|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Goals for Reaching Optimal Wellness: GROWell|
|Actual Study Start Date :||December 14, 2020|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: GROWell (Interactive Obesity Treatment Approach)
With Self-regulation Theory as the framework, the Interactive Obesity Treatment Approach Adapted for Pregnancy/Postpartum includes four components: (1) personalized goal setting, (2) daily support and educational messages, (3) self-monitoring of behavior with tailored feedback, and (4) skills training. Each component aligns with the self- regulatory processes shown in previous studies to be necessary for behavior change. All interactions with participants are via text using a cell phone.
Behavioral: GROWell (Interactive Obesity Treatment Approach)
Personalized messaging via cell phone to support healthy eating behaviors during pregnancy and through 6 months postpartum
Active Comparator: Attention Support Control
The attention control will be delivered using text messaging to reduce the potential placebo effect that interacting with our mHealth system may have on pregnancy weight gain and postpartum weight loss. Information will be provided to control group participants that is specific to pregnancy, labor, delivery, and early infancy, but not to diet. Texts are specific to the participant's partner, pregnancy, employment, and breastfeeding plans/status.
Behavioral: Attention Support Control
Personalized messaging via cell phone to support healthy behaviors during pregnancy and through 6 months postpartum
- Gestational Weight Gain [ Time Frame: Mid-study (25-30 weeks) ]Gestational weight gain will be calculated as: [weight(delivery) - weight(preconception)]. Women will be categorized as gaining excess gestational weight if they started pregnancy as overweight and gained more than 25 pounds or started pregnancy as obese and gained more than 20 pounds.
- Postpartum Weight Retention [ Time Frame: End of study (50-55 weeks) ]Postpartum weight retention will be calculated as: [weight(6 months postpartum) - weight(preconception)]. Women will be categorized as experiencing postpartum weight retention if postpartum weight at 6 months is greater than 1.05*preconception weight.
- Adherence to text-based self- monitoring [ Time Frame: mid-study (25-30 weeks) and post-study (50-55 weeks) ]Measured cumulatively by week as the number of times a participant responds to weekly prompts to report on her progress to the number of times she was prompted, calculated to a percent separately for prenatal and postnatal periods.
- Adherence to prescribed goals [ Time Frame: mid-study (25-30 weeks) and post-study (50-55 weeks) ]Measured cumulatively by week as the proportion of goals for which a participant has "good adherence" during the previous week, defined as adhering to the goal 5/7 days, or >70%, calculated to a percent and separately for prenatal and postpartum periods.
- Delivery type [ Time Frame: mid-study (25-30 weeks) ]Categorical as cesarean or vaginal delivery
- Fetal growth abnormalities [ Time Frame: mid-study (25-30 weeks) ]categorical as small-for-gestational age, large-for- gestational-age, macrosomia, or none.
- Pregnancy complications [ Time Frame: mid-study (25-30 weeks) ]categorical as gestational diabetes, hypertension, preeclampsia/eclampsia, placental abruption, fetal death, antepartum admission, preterm birth with and without NICU admission, none
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04449432
|Contact: William Pacuilla||(530) email@example.com|
|Contact: Grace Liu||(530) firstname.lastname@example.org|
|United States, California|
|Davis, California, United States, 95616|
|Contact: Grace Liu, JD 530-754-7700 email@example.com|
|Principal Investigator:||Leigh Ann Simmons, PhD||University of California, Davis|