Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04449432
Other study ID # 1399548
Secondary ID 1R01NR017659-01A
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 14, 2020
Est. completion date March 31, 2024

Study information

Verified date November 2023
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Despite the negative consequences to maternal-child health from women gaining too much weight during pregnancy, up to 62% of overweight and obese women gain more pregnancy weight than is recommended. This project will establish the efficacy of Goals for Reaching Optimal Wellness (GROWell), an mHealth tool for achieving appropriate pregnancy weight gain and promoting postpartum weight loss among women who enter pregnancy overweight or obese. GROWell will fill a gap in research and clinical care by providing a validated, standalone mHealth tool for weight control during pregnancy and postpartum, which is a currently lacking resource.


Description:

Read more »
Read more »

Study Design


Intervention

Behavioral:
GROWell (Interactive Obesity Treatment Approach)
Personalized messaging via cell phone to support healthy eating behaviors during pregnancy and through 6 months postpartum
Attention Support Control
Personalized messaging via cell phone to support healthy behaviors during pregnancy and through 6 months postpartum

Locations

Country Name City State
United States UC Davis Davis California

Sponsors (4)

Lead Sponsor Collaborator
University of California, Davis Duke University, National Institute of Nursing Research (NINR), Pattern Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Delivery type Categorical as cesarean or vaginal delivery mid-study (25-30 weeks)
Other Fetal growth abnormalities categorical as small-for-gestational age, large-for- gestational-age, macrosomia, or none. mid-study (25-30 weeks)
Other Pregnancy complications categorical as gestational diabetes, hypertension, preeclampsia/eclampsia, placental abruption, fetal death, antepartum admission, preterm birth with and without NICU admission, none mid-study (25-30 weeks)
Primary Gestational Weight Gain 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. Mid-study (25-30 weeks)
Primary Postpartum Weight Retention 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. End of study (50-55 weeks)
Secondary Adherence to text-based self- monitoring 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. mid-study (25-30 weeks) and post-study (50-55 weeks)
Secondary Adherence to prescribed goals 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. mid-study (25-30 weeks) and post-study (50-55 weeks)
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03994419 - PErioperAtive CHildhood ObesitY
Recruiting NCT05354245 - Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL) N/A
Completed NCT03602001 - Attentive Eating for Weight Loss N/A
Recruiting NCT06269159 - The Power of 24-hour: Co-designing Intervention Components
Completed NCT03377244 - Healthy Body Healthy Souls in the Marshallese Population N/A
Completed NCT02996864 - Location-based Smartphone Technology to Guide College Students Healthy Choices Ph II N/A
Terminated NCT03914066 - A Group-based Treatment of Overweight and Obesity in Primary Care N/A
Completed NCT04647149 - Effects of Early and Delayed Time-restricted Eating in Adults With Overweight and Obesity N/A
Completed NCT03685656 - Effect of ANACA3 Slimming Gel on Loss of Abdominal and Thigh Circumferences in Healthy Volunteers N/A
Completed NCT05051579 - A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities Phase 2
Completed NCT04611477 - Effect of Synbiotic 365 on Body Composition in Overweight and Obese Individuals N/A
Active, not recruiting NCT05330247 - Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes - The Meal Box Study N/A
Completed NCT03599115 - Effects of Inhibitory Control Training in Eating Behaviors N/A
Recruiting NCT05938894 - Train Your Brain - Executive Function N/A
Recruiting NCT06094231 - Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study N/A
Recruiting NCT05987306 - A Self-compassion Focused Intervention for Internalized Weight Bias and Weight Loss N/A
Completed NCT03792685 - Looking for Personalized Nutrition for Obesity/Type 2 Diabetes Mellitus Prevention N/A
Completed NCT05055362 - Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study N/A
Completed NCT04520256 - Rapid Evaluation of Innovative Intervention Components to Maximize the Health Benefits of Behavioral Obesity Treatment Delivered Online: An Application of Multiphase Optimization Strategy Phase 2/Phase 3
Completed NCT04979234 - A Single Centre, Prospective Feasibility Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) on Severe Obstructive Sleep Apnea Syndrome N/A