Promoting Appropriate Weight Gain Pregnant Women

NCT ID: NCT04180878

Last Updated: 2024-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-26

Study Completion Date

2016-02-03

Brief Summary

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The purpose of this study is to learn if engaging in group based phone counseling (GBPC) and an interactive physical activity monitoring system can help pregnant women gain an appropriate amount of weight during pregnancy.

Detailed Description

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Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control Arm

Participants in this group were informed to continue to receive usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Arm

Received an interactive physical activity monitoring system (the GruveĀ®).

Group Type EXPERIMENTAL

Intervention

Intervention Type BEHAVIORAL

Participants received a interactive physical activity monitoring system that allowed study personnel to monitor their activity level.

Intervention Arm 2

Received an interactive physical activity monitoring system (the GruveĀ®) and group based phone counseling (GBPC).

Group Type EXPERIMENTAL

Intervention 2

Intervention Type BEHAVIORAL

Participants received an interactive physical activity monitoring system, an electronic scale to report weekly body weight, weekly hour long conference calls with structured interactive educational lessons led by Health Educator, dietary recalls were completed at three different time points during their participation, and study personnel monitored physical activity levels weekly.

Interventions

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Intervention

Participants received a interactive physical activity monitoring system that allowed study personnel to monitor their activity level.

Intervention Type BEHAVIORAL

Intervention 2

Participants received an interactive physical activity monitoring system, an electronic scale to report weekly body weight, weekly hour long conference calls with structured interactive educational lessons led by Health Educator, dietary recalls were completed at three different time points during their participation, and study personnel monitored physical activity levels weekly.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 12-16 weeks pregnant
* Pre-pregnancy BMI between 22 kg/m2 to 45 kg/m2

Exclusion Criteria

* Diabetes
* Pre-eclampsia
* Hypertension
* Other metabolic abnormalities
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Holly R Hull, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Other Identifiers

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13749

Identifier Type: -

Identifier Source: org_study_id

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