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Lifestyle Intervention for Pregnancy Weight Gain

Q: What are the criteria for being accepted as a participant in this trial?

Conformity to the criteria for this trial necessitates a gestational weight gain and an age limit between 18-45. The medical study is currently recruiting approximately 2040 individuals.

Q: Is this study accommodating participants aged 40 and above?

This research protocol requires that participants are between 18 and 45 years old. In comparison, there are 99 trials targeting minors while 288 studies recruit individuals over 65 years of age.

Q: How many participants are engaged in this research study?

Affirmative. The information on clinicaltrials.gov confirms that the medical trial, which was initially shared on January 21st 2021, is currently recruiting participants. Approximately 2040 people must be enrolled from two different clinical locations.

Q: Are more participants being sought for this investigation?

Affirmative. Clinicaltrials.gov reports that the clinical trial is actively recruiting, having been posted on January 21st 2021 and last revised on March 4th 2022. 2040 patients need to be enrolled from two different health facilities.

N/A

Recruiting

Research Sponsored by Kaiser Permanente

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 from birth to 6 months of age

Awards & highlights

Study Summary

This trial is investigating whether a mobile health intervention can help overweight and obese women achieve appropriate gestational weight gain. The intervention includes an mHealth tool, text messages, and 1:1 telephone coaching sessions. Maternal and infant outcomes will be assessed.

Who is the study for?

This trial is for overweight or obese pregnant women with a pre-pregnancy BMI of 25 to <40, who are patients at Kaiser Permanente in San Francisco or Oakland. Participants must have access to a smartphone and Wi-Fi, understand English, and not be on bed rest or planning to move during the study.Check my eligibility

What is being tested?

The trial tests a mobile health intervention aimed at helping participants maintain pregnancy weight gain within recommended limits. It includes an mHealth tool, personalized texts, and telephone coaching sessions for those not meeting guidelines—compared against usual medical care.See study design

What are the potential side effects?

Since this is a lifestyle intervention involving counseling and technology-based tools rather than medication, no direct side effects are expected from the intervention itself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from birth to 6 months of age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from birth to 6 months of age

This trial's timeline: 3 weeks for screening, Varies for treatment, and from birth to 6 months of age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of women meeting the Institute of Medicine's GWG recommendation

Rate of total GWG

Total gestational weight gain (GWG)

Secondary outcome measures

Change in moderate to vigorous physical activity (in MET hrs/week) as assessed by the Pregnancy Physical Activity Questionnaire (PPAQ)

GWG trajectory throughout pregnancy

Infant growth (BMI z-score)

+4 more

Side effects data

From 2008 Phase 2 trial • 114 Patients • NCT00151411

35%

Diarrhea

22%

headache/migraine

22%

common cold/respiratory tract infection

16%

nausea and/or vomiting

15%

flu

13%

dysmenorrhea/cramps

11%

stomach/abdominal pain or discomfort

musculoskeletal

vaginal infection

dizziness

hair loss

dental issues

fatigue

flatulence

bladder infection

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Metformin

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Lifestyle InterventionExperimental Treatment1 Intervention

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.

Group II: Usual Care - ControlActive Control1 Intervention

Usual Medical Care

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lifestyle Intervention

2001

Completed Phase 2

~8880

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Kaiser PermanenteLead Sponsor

538 Previous Clinical Trials

24,111,748 Total Patients Enrolled

2 Trials studying Gestational Weight Gain

473 Patients Enrolled for Gestational Weight Gain

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,313,463 Total Patients Enrolled

4 Trials studying Gestational Weight Gain

982 Patients Enrolled for Gestational Weight Gain

Media Library

Lifestyle Intervention Clinical Trial Eligibility Overview. Trial Name: NCT03880461 — N/A

Gestational Weight Gain Research Study Groups: Lifestyle Intervention, Usual Care - Control

Gestational Weight Gain Clinical Trial 2023: Lifestyle Intervention Highlights & Side Effects. Trial Name: NCT03880461 — N/A

Lifestyle Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT03880461 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the criteria for being accepted as a participant in this trial?

"Conformity to the criteria for this trial necessitates a gestational weight gain and an age limit between 18-45. The medical study is currently recruiting approximately 2040 individuals."

Answered by AI

Is this study accommodating participants aged 40 and above?

"This research protocol requires that participants are between 18 and 45 years old. In comparison, there are 99 trials targeting minors while 288 studies recruit individuals over 65 years of age."

Answered by AI

How many participants are engaged in this research study?

"Affirmative. The information on clinicaltrials.gov confirms that the medical trial, which was initially shared on January 21st 2021, is currently recruiting participants. Approximately 2040 people must be enrolled from two different clinical locations."

Answered by AI

Are more participants being sought for this investigation?

"Affirmative. Clinicaltrials.gov reports that the clinical trial is actively recruiting, having been posted on January 21st 2021 and last revised on March 4th 2022. 2040 patients need to be enrolled from two different health facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women

2021. "A Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03880461.

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