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Lifestyle Intervention for Pregnancy Weight Gain

N/A

Waitlist Available

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

Must not have

Placed on bed rest at time of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up between 12 weeks and 33 weeks of pregnancy

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently on bed rest.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ between 12 weeks and 33 weeks of pregnancy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~between 12 weeks and 33 weeks of pregnancy

This trial's timeline: 3 weeks for screening, Varies for treatment, and between 12 weeks and 33 weeks of pregnancy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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

Overall diet quality according to the Healthy Eating Index-2015 (HEI-2015)

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~8370

0 / 1Eligibility criteria met