ObesityNCT01408147

Prevention of Postpartum Weight Retention in Low Income WIC Women

A study of Obesity, run by California Polytechnic State University-San Luis Obispo at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will examine the effects of an online behavioral intervention to promote weight loss in low income postpartum women in the WIC program. Read more about this study

Who is it for?: Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Obesity
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 371 participants
Where: 2 sitesUnited States
Study dates: Jul 2011to Dec 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Women
Age 18-40 years.
Delivery within 6-52 weeks
Exceed pre-pregnancy weight by at least 4.5 kg (10 pounds) or current body mass index (BMI) >/= 25
Current BMI > 22
English or Spanish speaking

Show all 9Show fewer

Has internet access at home or a landline
Literacy of at least 5th grade reading level
Has a cell phone

Who cannot join

Pregnant or planning to become pregnant
Relocating in the next year
Serious psychological problems (untreated depression, schizophrenia, bipolar disorder) or medical problem (i.e. heart disease, cancer, renal disease and diabetes), for which physician supervision of diet and exercise prescription is needed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of North Carolina
Chapel Hill, North Carolina
California Polytechnic State University
San Luis Obispo, California, 93401

Other trials in United States

About this study

This study will examine the effects of an online behavioral intervention to promote weight loss in low income postpartum women in the WIC program.

Read the detailed description

This program is designed to reduce postpartum weight retention in low income women in the WIC program. The weight loss program will be delivered over the internet and will use behavioral weight loss techniques.

Conditions: Obesity
Being tested: Online postpartum weight control
Keywords: Postpartum weight retention, Low income women, WIC, Online
Medical subject headings: Obesity, Gestational Weight Gain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Online postpartum weight controlBehavioural
Also called Internet-based treatment for weight loss
The intervention group will be given access to an online weight loss program supplemented by monthly group meetings.

Study groups in NCT01408147
Study group	Role	What they receive
Treatment Group	Active comparator	This group will be allowed access to an online weight loss program. The program is designed to help low income women lose weight through lifestyle intervention. Receives: Behavioral: Online postpartum weight control
Standard WIC care	No intervention	The control group will received Standard Care as provided through WIC.

What is being measured

The primary outcome is the main question the study is designed to answer.

Weight
Women randomized to the weight loss group will be assessed over time at study entry, 6 months, and 12 months.
The primary outcome is change from entry to the endpoint at 12 months.
Measured: 12 months

Secondary outcomes (1)

Calorie Intake
Calorie intake was measured over time at study entry, 6 and 12 months. The primary outcome is change from entry to 12 months.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Dec 2016

First posted3 Aug 2011 (estimated)
Study startJul 2011
Primary completionSep 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for ObesityStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 371 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01408147
Sponsor's protocol ID: 1R01DK087889-01A1
Status last verified: Aug 2020
First submitted: 29 Jul 2011
Last updated: 16 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Phelan S, Hagobian T, Brannen A, Hatley KE, Schaffner A, Munoz-Christian K, Tate DF. Effect of an Internet-Based Program on Weight Loss for Low-Income Postpartum Women: A Randomized Clinical Trial. JAMA. 2017 Jun 20;317(23):2381-2391. doi: 10.1001/jama.2017.7119.
PubMed 28632867
Martin CL, Tate DF, Schaffner A, Brannen A, Hatley KE, Diamond M, Munoz-Christian K, Pomeroy J, Sanchez T, Mercado A, Hagobian T, Phelan S. Acculturation Influences Postpartum Eating, Activity, and Weight Retention in Low-Income Hispanic Women. J Womens Health (Larchmt). 2017 Dec;26(12):1333-1339. doi: 10.1089/jwh.2016.6154. Epub 2017 Aug 17.
PubMed 28816589
Phelan S, Brannen A, Erickson K, Diamond M, Schaffner A, Munoz-Christian K, Stewart A, Sanchez T, Rodriguez VC, Ramos DI, McClure L, Stinson C, Tate DF. 'Fit Moms/Mamas Activas' internet-based weight control program with group support to reduce postpartum weight retention in low-income women: study protocol for a randomized controlled trial. Trials. 2015 Feb 25;16:59. doi: 10.1186/s13063-015-0573-9.
PubMed 25887964
Bennion KA, Tate D, Munoz-Christian K, Phelan S. Impact of an Internet-Based Lifestyle Intervention on Behavioral and Psychosocial Factors During Postpartum Weight Loss. Obesity (Silver Spring). 2020 Oct;28(10):1860-1867. doi: 10.1002/oby.22921. Epub 2020 Sep 4.
PubMed 32888250

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevention of Postpartum Weight Retention in Low Income WIC Women
ClinicalTrials.gov ID: NCT01408147
Acronym / sponsor ID: 1R01DK087889-01A1
Conditions: Obesity
Keywords: Postpartum weight retention, Low income women, WIC, Online
Study type: Interventional
Recruitment status: Completed
Enrolment: 371 participants (actual)
Lead sponsor: California Polytechnic State University-San Luis ObispoUniversity, hospital or other
Collaborators: University of North Carolina, Chapel Hill
Study start: Jul 2011
Primary completion: Sep 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 3 Aug 2011 (estimated)
Results: Posted 16 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will examine the effects of an online behavioral intervention to promote weight loss in low income postpartum women in the WIC program.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Treatment Group	Active comparator	Behavioral: Online postpartum weight controlThis group will be allowed access to an online weight loss program. The program is designed to help low income women lose weight through lifestyle intervention.
Standard WIC care	No intervention	–The control group will received Standard Care as provided through WIC.

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Women
Age 18-40 years.
Delivery within 6-52 weeks
Exceed pre-pregnancy weight by at least 4.5 kg (10 pounds) or current body mass index (BMI) >/= 25
Current BMI > 22

Key exclusion criteria (3 listed)

Pregnant or planning to become pregnant
Relocating in the next year
Serious psychological problems (untreated depression, schizophrenia, bipolar disorder) or medical problem (i.e. heart disease, cancer, renal disease and diabetes), for which physician supervision of diet and exercise prescription is needed.

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
Online postpartum weight controlAlso: Internet-based treatment for weight lossThe intervention group will be given access to an online weight loss program supplemented by monthly group meetings.	Behavioural	Treatment Group

Primary outcome

Weight
Time frame: 12 months
Women randomized to the weight loss group will be assessed over time at study entry, 6 months, and 12 months. The primary outcome is change from entry to the endpoint at 12 months.

1 secondary outcome

Calorie Intake
Time frame: 12 months

Results and safety

Results posted to the registry on 16 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Group	174	174
Standard WIC Care	197	196

Primary outcome: Weight

Time frame: 12 months. Least squares mean (95% Confidence Interval). Unit: kg

Measure	Treatment Group n = 174	Standard WIC Care n = 196
Value	-3.2 (-4.1 to -2.4)	-0.9 (-1.7 to -0.1)

Treatment Group vs Standard WIC Care: Mean Difference (Final Values): 2.3, p <0.0001, Mixed Models Analysis

Population analysed: This cluster randomized trial included 11 clinics. Participant numbers reflect number of people randomized within the clinics.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Group	0 of 174 (0%)	16 of 174 (9.2%)	Not reported
Standard WIC Care	0 of 196 (0%)	15 of 196 (7.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28632867Phelan S, Hagobian T, Brannen A, Hatley KE, Schaffner A, Munoz-Christian K, Tate DF. Effect of an Internet-Based Program on Weight Loss for Low-Income Postpartum Women: A Randomized Clinical Trial. JAMA. 2017 Jun 20;317(23):2381-2391. doi: 10.1001/jama.2017.7119.
Background: PubMed 28816589Martin CL, Tate DF, Schaffner A, Brannen A, Hatley KE, Diamond M, Munoz-Christian K, Pomeroy J, Sanchez T, Mercado A, Hagobian T, Phelan S. Acculturation Influences Postpartum Eating, Activity, and Weight Retention in Low-Income Hispanic Women. J Womens Health (Larchmt). 2017 Dec;26(12):1333-1339. doi: 10.1089/jwh.2016.6154. Epub 2017 Aug 17.
Results publication: PubMed 25887964Phelan S, Brannen A, Erickson K, Diamond M, Schaffner A, Munoz-Christian K, Stewart A, Sanchez T, Rodriguez VC, Ramos DI, McClure L, Stinson C, Tate DF. 'Fit Moms/Mamas Activas' internet-based weight control program with group support to reduce postpartum weight retention in low-income women: study protocol for a randomized controlled trial. Trials. 2015 Feb 25;16:59. doi: 10.1186/s13063-015-0573-9.
Derived from this study: PubMed 32888250Bennion KA, Tate D, Munoz-Christian K, Phelan S. Impact of an Internet-Based Lifestyle Intervention on Behavioral and Psychosocial Factors During Postpartum Weight Loss. Obesity (Silver Spring). 2020 Oct;28(10):1860-1867. doi: 10.1002/oby.22921. Epub 2020 Sep 4.

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

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.

Suzanne Phelan, PhD. principal investigator

California Polytechnic State University-San Luis Obispo

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Obesity, run by California Polytechnic State University-San Luis Obispo at 2 sites 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 9 inclusion and 3 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 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 16 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Weight (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01408147, which also lists 4 linked publications.

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 16 Sep 2020.