NCT04330976

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
Last Updated

April 2, 2020

Status Verified

March 1, 2020

Enrollment Period

12 months

First QC Date

February 28, 2020

Last Update Submit

March 31, 2020

Conditions

Gestational Weight Gain

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Nutrition and physical activity intervention

EXPERIMENTAL
Behavioral: Nutrition and physical activity intervention

Control

OTHER
Behavioral: Control

Interventions

Nutrition and physical activity interventionBEHAVIORAL

Messages sent on nutrition and physical activity in pregnancy

Nutrition and physical activity intervention
ControlBEHAVIORAL

Messages sent on general health during pregnancy

Control

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hawaii

Honolulu, Hawaii, 96822, United States

Location

MeSH Terms

Conditions

Gestational Weight Gain

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Weight GainBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2020

First Posted

April 2, 2020

Study Start

October 30, 2017

Primary Completion

October 29, 2018

Study Completion

June 2, 2019

Last Updated

April 2, 2020

Record last verified: 2020-03

Locations

US(1)