Gestational Weight GainNCT04330976
Preventing Excessive Gestational Weight Gain Via Short Mobile Messages in WIC
A study testing Nutrition and physical activity intervention in people with Gestational Weight Gain, run by University of Hawaii at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Weight Gain
- What is being tested?
- Nutrition and physical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2017to 2 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- conditions requiring a special diet
- multiparous pregnancies
- unable to consent to participate
- unwilling to be randomized
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventing Excessive Gestational Weight Gain Via Short Mobile Messages in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)
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.
- Conditions
- Gestational Weight Gain
- Being tested
- Nutrition and physical activity intervention, Control
- Medical subject headings
- Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition and physical activity interventionBehavioural
Messages sent on nutrition and physical activity in pregnancy
ControlBehavioural
Messages sent on general health during pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Nutrition and physical activity intervention | Experimental | Not described Receives: Behavioral: Nutrition and physical activity intervention |
| Control | Other | Not described Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change between pre-pregnancy weight and last weight taken before delivery
Total weight gained during pregnancy
Measured: From date of randomization until delivery of child (e.g. up to 25 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start30 Oct 2017
- Primary completion29 Oct 2018
- Study completion2 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330976
- Sponsor's protocol ID
- 5U54MD008149-09
- Status last verified
- Mar 2020
- First submitted
- 28 Feb 2020
- Last updated
- 2 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Excessive Gestational Weight Gain Via Short Mobile Messages in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)
- ClinicalTrials.gov ID
- NCT04330976
- Acronym / sponsor ID
- 5U54MD008149-09
- Conditions
- Gestational Weight Gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 29 Oct 2018 (actual)
- Study completion
- 2 Jun 2019 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition and physical activity intervention | Experimental | Behavioral: Nutrition and physical activity intervention |
| Control | Other | Behavioral: Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- conditions requiring a special diet
- multiparous pregnancies
- unable to consent to participate
- unwilling to be randomized
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition and physical activity interventionMessages sent on nutrition and physical activity in pregnancy | Behavioural | Nutrition and physical activity intervention |
| ControlMessages sent on general health during pregnancy | Behavioural | Control |
Primary outcome
Change between pre-pregnancy weight and last weight taken before delivery
Time frame: From date of randomization until delivery of child (e.g. up to 25 weeks)
Total weight gained during pregnancy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
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Time-restricted Eating Among Pregnant Females With Severe Obesity
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Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study
Pregnancies at Increased Risk for Excessive Gestational Weight Gain, Ecological Momentary Assessment and Intervention
Not yet recruiting
Healthy Adaptation to Pregnancy, Postpartum and Parenthood
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition and physical activity intervention in people with Gestational Weight Gain, run by University of Hawaii at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change between pre-pregnancy weight and last weight taken before delivery (time frame: From date of randomization until delivery of child (e.g. up to 25 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.