ObesityNCT01081340
Building Social Networks to Enhance Postpartum Weight Loss and Appropriate Infant Feeding Practices
A study testing Social network building intervention and Home visit in people with Obesity, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this study is to examine whether we can use social networks to spread health information and health behaviors that 1) support women in returning to their pre-pregnancy weight after delivery; and 2) promote healthy infant feeding practices. 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
- Obesity
- What is being tested?
- Social network building intervention and Home visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Aug 2011
- 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
- Latina (self-defined, or born in Central or South America)
- Spanish-speaking and/or English-speaking,
- 18 years of age or older
- less than 24 weeks pregnant
- did or did not have a termination of a previous pregnancy before 20 weeks
- has not carried a pregnancy to term
- normal, overweight or obese (pre-pregnancy BMI >18.5 and <39)
Who cannot join
- non-Latina,
- non-Spanish-speaking or non-English speaking
- less than 18 years of age
- more than 24 weeks pregnant
- had a termination of a previous pregnancy after 20 weeks
- multiparous
Show all 9Show fewer
- underweight (pre-pregnancy BMI < 18.5)
- morbidly obese (pre-pregnancy BMI ≥ 39)
- currently enrolled in another program that targets weight, physical activity, or nutrition
Trial locations and contacts
1 site in 1 country.
United States1 site
Coleman Regional Community Center - Parks & Rec Department
Nashville, Tennessee, 37211
About this study
The purpose of this study is to examine whether we can use social networks to spread health information and health behaviors that 1) support women in returning to their pre-pregnancy weight after delivery; and 2) promote healthy infant feeding practices.
Read the detailed description
The long-term goal of this research is to prevent obesity-related adverse health outcomes for future generations by applying information emerging from social network studies to the development of new population-based behavioral interventions. There are a number of critical periods during fetal and infant development that appear to influence the later development of obesity. Interventions that prevent insult to these critical windows from occurring could improve children's life course trajectories. This project sets the groundwork for examining whether social networks could explicitly be utilized to prevent obesity from developing by transmitting health information and health behaviors that 1) prevent postpartum weight retention in first time mothers and 2) promote appropriate infant feeding practices. The secondary aim is to assess which individual-level network-related characteristics best predict postpartum body composition and infant feeding practices.
- Conditions
- Obesity
- Being tested
- Social network building intervention, Home visit
- Keywords
- gestational weight gain, postpartum weight loss, breastfeeding, overfeeding
- Medical subject headings
- Obesity, Gestational Weight Gain, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social network building interventionBehavioural
Group support and health education sessions weekly during third trimester and once every two weeks until 6 months postpartum
Home visitBehavioural
Three home visits during third trimester and three during postpartum period until 6 months postpartum
| Study group | Role | What they receive |
|---|---|---|
| Social network building intervention | Experimental | Healthy lifestyle intervention focused on building reciprocal social ties between the intervention group members Receives: Behavioral: Social network building intervention |
| Home visit | Active comparator | Home visits focused on preventable infant injuries Receives: Behavioral: Home visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight (kg)
gestational weight gain and postpartum weight loss
Measured: 6 times over 10 months
Secondary outcomes (7)
Body composition
BIA postpartum
Measured: 3 times over 6 months
Infant feeding practices
duration of breastfeeding, use of supplemental fluids, overfeeding, timing of the introduction of solids
Measured: 3 times over 6 months
Social network structure
number and type of relationships
Measured: 6 times over 10 months
Waist Circumference
Measured: 3 times over 6 months
Depression
Measured: 6 times over 10 months
Nutrition
Fat/Fruit/Vegetable intake
Measured: 6 times over 10 months
Physical Activity
self-report
Measured: 6 times over 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Sabina B Gesell, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081340
- Sponsor's protocol ID
- IRB00034677
- Status last verified
- Aug 2018
- First submitted
- 3 Mar 2010
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Social Networks to Enhance Postpartum Weight Loss and Appropriate Infant Feeding Practices
- ClinicalTrials.gov ID
- NCT01081340
- Acronym / sponsor ID
- IRB00034677
- Conditions
- Obesity
- Keywords
- gestational weight gain, postpartum weight loss, breastfeeding, overfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- May 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 5 Mar 2010 (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.
The purpose of this study is to examine whether we can use social networks to spread health information and health behaviors that 1) support women in returning to their pre-pregnancy weight after delivery; and 2) promote healthy infant feeding practices.
Detailed description
The long-term goal of this research is to prevent obesity-related adverse health outcomes for future generations by applying information emerging from social network studies to the development of new population-based behavioral interventions. There are a number of critical periods during fetal and infant development that appear to influence the later development of obesity. Interventions that prevent insult to these critical windows from occurring could improve children's life course trajectories. This project sets the groundwork for examining whether social networks could explicitly be utilized to prevent obesity from developing by transmitting health information and health behaviors that 1) prevent postpartum weight retention in first time mothers and 2) promote appropriate infant feeding practices. The secondary aim is to assess which individual-level network-related characteristics best predict postpartum body composition and infant feeding practices.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social network building intervention | Experimental | Behavioral: Social network building interventionHealthy lifestyle intervention focused on building reciprocal social ties between the intervention group members |
| Home visit | Active comparator | Behavioral: Home visitHome visits focused on preventable infant injuries |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Latina (self-defined, or born in Central or South America)
- Spanish-speaking and/or English-speaking,
- 18 years of age or older
- less than 24 weeks pregnant
- did or did not have a termination of a previous pregnancy before 20 weeks
Key exclusion criteria (9 listed)
- non-Latina,
- non-Spanish-speaking or non-English speaking
- less than 18 years of age
- more than 24 weeks pregnant
- had a termination of a previous pregnancy after 20 weeks
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 |
|---|---|---|
| Social network building interventionGroup support and health education sessions weekly during third trimester and once every two weeks until 6 months postpartum | Behavioural | Social network building intervention |
| Home visitThree home visits during third trimester and three during postpartum period until 6 months postpartum | Behavioural | Home visit |
Primary outcome
Weight (kg)
Time frame: 6 times over 10 months
gestational weight gain and postpartum weight loss
7 secondary outcomes
Body composition
Time frame: 3 times over 6 months
Infant feeding practices
Time frame: 3 times over 6 months
Social network structure
Time frame: 6 times over 10 months
Waist Circumference
Time frame: 3 times over 6 months
Depression
Time frame: 6 times over 10 months
Nutrition
Time frame: 6 times over 10 months
Physical Activity
Time frame: 6 times over 10 months
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 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Sabina B Gesell, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social network building intervention and Home visit in people with Obesity, run by Wake Forest University Health Sciences 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 7 inclusion and 9 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 Aug 2018. 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?
Weight (kg) (time frame: 6 times over 10 months). 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 13 Aug 2018.