Preventing Excessive Gestational Weight Gain Via Short Mo... | NCT04330976

Studies
Preventing Excessive Gestational Weight Gain Via Short Mobile Messages in WIC

NCT04330976

Sponsor

University of Hawaii

Status

Completed

Last Update Posted

Apr 2, 2020Actual

Enrollment

83Actual

Phase

Not Applicable

Conditions

Gestational Weight Gain

Interventions

Nutrition and physical activity intervention
Control

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 30, 2017Actual

Primary Completion Date

Oct 29, 2018Actual

Completion Date

Jun 2, 2019Actual

First Submitted Date

Feb 28, 2020

First Submission Date that Met QC Criteria

Mar 31, 2020

First Posted Date

Apr 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2020

Last Update Posted Date

Apr 2, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this trial was to investigate the effect of educational short message service (SMS), or text messages, on gestational weight gain (GWG) in a low-income population.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

83Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nutrition and physical activity intervention	Experimental		Behavioral: Nutrition and physical activity intervention
Control	Other		Behavioral: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nutrition and physical activity intervention	Behavioral	Messages sent on nutrition and physical activity in pregnancy	Nutrition and physical activity intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change between pre-pregnancy weight and last weight taken before delivery	Total weight gained during pregnancy	From date of randomization until delivery of child (e.g. up to 25 weeks)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

15-20 weeks gestational age and 18 years of age or older at time of recruitment
body mass index (BMI) of 25-45 kg/m2 in the first trimester
possession of a cellular phone with the ability to receive text messages without a charge

Exclusion Criteria:

conditions requiring a special diet
multiparous pregnancies
unable to consent to participate
unwilling to be randomized

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Hawaii		Honolulu	Hawaii	96822	United States

Condition Browse Module

MeSH Terms

ID	Term
D000078064	Gestational Weight Gain

Ancestor Terms

ID	Term
D015430	Weight Gain
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009752	Nutritional Status

Ancestor Terms

ID	Term
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D006304	Health Status

Browse Leaves

Not provided

Browse Branches

Not provided