Health PromotionNCT00061386
Improving Health in Low Income Women Following the Birth of a Child
A study testing Nutrition and physical activity program in people with Health Promotion, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
This study will evaluate a community-based program to improve diet and physical activity in women during the first 12 months following the birth of a child. The program is designed to complement existing federal programs for low-income families and is directed toward low-income, postpartum, multi-ethnic women. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Promotion
- What is being tested?
- Nutrition and physical activity program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 680 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2001to Mar 2004
- 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 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Less than 20 weeks postpartum
- Receive services of USDA's Special Supplemental Food Program for Women, Infants, and Children (WIC)
Who cannot join
- Less than 18 years of age upon recruitment
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard School of Public Health, SHDH Department
Boston, Massachusetts, 021115
About this study
Official title: Reducing Disease Risk in Low Income Postpartum Women
This study will evaluate a community-based program to improve diet and physical activity in women during the first 12 months following the birth of a child. The program is designed to complement existing federal programs for low-income families and is directed toward low-income, postpartum, multi-ethnic women.
Read the detailed description
The postpartum period is a window of opportunity to promote behaviors that reduce the risk of chronic disease and benefit reproductive health. The Expanded Food and Nutrition Education Program (EFNEP) is an educational program delivered by community-based paraprofessional's that aims to improve dietary and activity patterns among low income, multi-ethnic women during the postpartum period. This study will evaluate the efficacy of the EFNEP to impact the diet and activity patterns of women.
Women were recruited through the Special Supplemental Food Program for Women, Infants, and Children (WIC) and randomized to either the EFNEP group or a usual care group. Women in both groups will receive standard WIC care consisting of nutrition-risk and breastfeeding educational messages at postpartum and follow-up visits. Women in the EFNEP group participated in an additional two component intervention that included five home visits and motivational telephone calls from project staff.
Primary study outcomes were assessed at Months 1 and 12. Primary outcomes included fruit and vegetable intake, saturated fat intake, and physical activity. Secondary outcomes will include Body Mass Index and indicators of fat mass and distribution. The study will also analyze mediating and modifying factors, including social support and norms, perceived health status, smoking, television viewing, food insecurity, food and activity access, and utilization of federal programs and health care.
- Conditions
- Health Promotion
- Being tested
- Nutrition and physical activity program
- Keywords
- Postpartum, Low income, Diet, Physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition and physical activity programBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
fruit and vegetable intake
saturated fat intake
physical activity
Secondary outcomes (2)
body mass index
indicators of fat mass and distribution.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2003 (estimated)
- Study startMar 2001
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health PromotionStudies 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
- Factorial
- Masking
- Single blind
- Enrolment
- 680 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Karen E. Peterson, ScD, RD, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00061386
- Sponsor's protocol ID
- 5R01HD37368-4
- Other IDs
- 5R01HD037368
- Status last verified
- Sep 2005
- First submitted
- 27 May 2003
- Last updated
- 13 Sep 2005
- Results posted
- No
Publications
Peterson KE, Sorensen G, Pearson M, Hebert JR, Gottlieb BR, McCormick MC. Design of an intervention addressing multiple levels of influence on dietary and activity patterns of low-income, postpartum women. Health Educ Res. 2002 Oct;17(5):531-40. doi: 10.1093/her/17.5.531.
PubMed 12408198
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Disease Risk in Low Income Postpartum Women
- ClinicalTrials.gov ID
- NCT00061386
- Acronym / sponsor ID
- 5R01HD37368-4
- Conditions
- Health Promotion
- Keywords
- Postpartum, Low income, Diet, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 680 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Mar 2001
- Study completion
- Mar 2004
- First posted
- 28 May 2003 (estimated)
- 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.
This study will evaluate a community-based program to improve diet and physical activity in women during the first 12 months following the birth of a child. The program is designed to complement existing federal programs for low-income families and is directed toward low-income, postpartum, multi-ethnic women.
Detailed description
The postpartum period is a window of opportunity to promote behaviors that reduce the risk of chronic disease and benefit reproductive health. The Expanded Food and Nutrition Education Program (EFNEP) is an educational program delivered by community-based paraprofessional's that aims to improve dietary and activity patterns among low income, multi-ethnic women during the postpartum period. This study will evaluate the efficacy of the EFNEP to impact the diet and activity patterns of women.
Women were recruited through the Special Supplemental Food Program for Women, Infants, and Children (WIC) and randomized to either the EFNEP group or a usual care group. Women in both groups will receive standard WIC care consisting of nutrition-risk and breastfeeding educational messages at postpartum and follow-up visits. Women in the EFNEP group participated in an additional two component intervention that included five home visits and motivational telephone calls from project staff.
Primary study outcomes were assessed at Months 1 and 12. Primary outcomes included fruit and vegetable intake, saturated fat intake, and physical activity. Secondary outcomes will include Body Mass Index and indicators of fat mass and distribution. The study will also analyze mediating and modifying factors, including social support and norms, perceived health status, smoking, television viewing, food insecurity, food and activity access, and utilization of federal programs and health care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Less than 20 weeks postpartum
- Receive services of USDA's Special Supplemental Food Program for Women, Infants, and Children (WIC)
Key exclusion criteria (1 listed)
- Less than 18 years of age upon recruitment
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 program | Behavioural | – |
Primary outcome
fruit and vegetable intake
saturated fat intake
physical activity
2 secondary outcomes
body mass index
indicators of fat mass and distribution.
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 13 Sep 2005.
- Background: PubMed 12408198Peterson KE, Sorensen G, Pearson M, Hebert JR, Gottlieb BR, McCormick MC. Design of an intervention addressing multiple levels of influence on dietary and activity patterns of low-income, postpartum women. Health Educ Res. 2002 Oct;17(5):531-40. doi: 10.1093/her/17.5.531.
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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.
Karen E. Peterson, ScD, RD principal investigator
Harvard School of Public Health (HSPH)
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 program in people with Health Promotion, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 2 inclusion and 1 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 13 Sep 2005. 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?
fruit and vegetable intake. The study lists 3 primary outcomes in all. 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 NCT00061386, which also lists 1 linked publication.
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 13 Sep 2005.