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Behavioral Intervention
Interactive Obesity Treatment for Pregnancy
N/A
Waitlist Available
Led By Leigh Ann Simmons, PhD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up mid-study (25-30 weeks) and post-study (50-55 weeks)
Awards & highlights
Study Summary
This trial will establish the efficacy of an mHealth tool, GROWell, for achieving appropriate pregnancy weight gain and promoting postpartum weight loss among women who enter pregnancy overweight or obese.
Who is the study for?
The GROWell trial is for pregnant women who are overweight or obese with a BMI between 25 and 40. Participants should be in their first or early second trimester, not have given birth in the last year, and plan to deliver at UC Davis Medical Center. They must also be able to use text messaging.Check my eligibility
What is being tested?
This study tests the GROWell program, an mHealth tool designed to help manage weight during pregnancy and after giving birth. It will compare the effectiveness of this tool against standard attention support control in promoting healthy weight gain and postpartum weight loss.See study design
What are the potential side effects?
As GROWell is a digital health management tool focusing on education and behavior change rather than medication, it does not have direct medical side effects. However, participants may experience stress or frustration if they do not meet personal goals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ mid-study (25-30 weeks) and post-study (50-55 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~mid-study (25-30 weeks) and post-study (50-55 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Gestational Weight Gain
Postnatal Care
Secondary outcome measures
Adherence to prescribed goals
Adherence to text-based self- monitoring
Other outcome measures
Delivery type
Fetal growth abnormalities
Pregnancy Complications
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: GROWell (Interactive Obesity Treatment Approach)Experimental Treatment1 Intervention
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.
Group II: Attention Support ControlActive Control1 Intervention
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.
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Who is running the clinical trial?
University of California, DavisLead Sponsor
910 Previous Clinical Trials
4,706,511 Total Patients Enrolled
30 Trials studying Obesity
33,569 Patients Enrolled for Obesity
Pattern HealthUNKNOWN
National Institute of Nursing Research (NINR)NIH
579 Previous Clinical Trials
10,375,902 Total Patients Enrolled
17 Trials studying Obesity
3,462 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You stopped smoking less than 6 months ago.My BMI is between 25 and 40, and I can receive and respond to texts.You currently smoke cigarettes.You have a body mass index (BMI) higher than 40, which means you are severely overweight.You are pregnant with more than one baby.
Research Study Groups:
This trial has the following groups:- Group 1: GROWell (Interactive Obesity Treatment Approach)
- Group 2: Attention Support Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities remaining to join this experiment?
"Clinicaltrials.gov reveals that this clinical trail, posted on December 14th 2020 and last updated April 26th 2022, is currently seeking patients to participate."
Answered by AI
Are older individuals being included in the enrollment process of this experiment?
"This clinical trial seeks patients between 18 and 44 years of age as per its inclusion criteria. 123 studies are available for minors, while 372 exist to serve adults over 65."
Answered by AI
How many individuals have been included in this clinical trial to date?
"Affirmative. The information posted on clinicaltrials.gov demonstrates that this research project is still in the process of patient recruitment, having been first made available to the public on December 14th 2020 and last revised April 26th 2022. 480 participants will be recruited from a single site for this trial."
Answered by AI
What criteria must be met for someone to qualify as a participant in this clinical research?
"Each applicant must have a history of gestational weight gain and be within the prescribed age range (18-44) in order to join this clinical trial. The study is accommodating up to 480 participants."
Answered by AI
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