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Promoting Healthy Weight Gain During Pregnancy

Promoting Healthy Weight Gain During Pregnancy

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01117961
Enrollment
401
Registered
2010-05-06
Start date
2007-03-31
Completion date
2012-05-31
Last updated
2013-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight Gain

Keywords

Excessive gestational weight gain

Brief summary

Study goal is to determine whether behavioral lifestyle intervention during pregnancy can reduce the number of women who exceed the Institute of Medicine recommendations for weight gain during pregnancy. It is hypothesized that the intervention will reduce the number of women who exceed weight gain guidelines relative to standard care. The investigators also expect the intervention to reduce the proportion of women exceeding weight gain guidelines in both normal weight and overweight groups.

Interventions

BEHAVIORALLifestyle

Behavioral lifestyle intervention targeting diet and physical activity to reduce excessive gestational weight gain

Sponsors

California Polytechnic State University-San Luis Obispo
CollaboratorOTHER
Women and Infants Hospital of Rhode Island
CollaboratorOTHER
University of California, Berkeley
CollaboratorOTHER
The Miriam Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* non-smoking, adults, * \< 16 weeks gestation

Exclusion criteria

* medical comorbidities

Design outcomes

Primary

MeasureTime frameDescription
Percentage of women above the Institute of Medicine Guidelines for gestational weight gain40 weeksObjective measures of weight collected by trained staff on calibrated scales at study entry and after delivery to classify women as above or below the Institute of Medicine Guidelines for gestational weight gain

Secondary

MeasureTime frameDescription
Behavioral measures40 weeksThe Block Food Frequency questionnaire and Paffenbarger physical activity questionnaire will be used to assess diet and exercise behavior.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026