ObesityNCT02867631
Postpartum Weight Retention
A study testing 6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes in people with Obesity and Hypertension, run by University of Pennsylvania at 1 site in United States.
Trial summary
The Postpartum Weight Management Study is a true community-academic collaboration, bringing together Maternity Care Coalition (MCC) staff and the investigator, Dr. Charmaine Smith Wright from the University of Pennsylvania to address the needs of postpartum moms. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Hypertension, Depression
- What is being tested?
- 6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2017
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All women who speak English, and are within six weeks of delivering a live, term, single infants
Who cannot join
- Women who have multiple births or preterm (<38 weeks gestation) infants
Trial locations and contacts
1 site in 1 country.
United States1 site
Maternity Care Coalition
Philadelphia, Pennsylvania, 19130
About this study
Official title: A Randomized Controlled Trial (RCT) of an Intervention to Combat Postpartum Weight Retention
The Postpartum Weight Management Study is a true community-academic collaboration, bringing together Maternity Care Coalition (MCC) staff and the investigator, Dr. Charmaine Smith Wright from the University of Pennsylvania to address the needs of postpartum moms. The project is an innovative intervention to help moms lose weight after the birth of their baby. Helping mothers control their weight during pregnancy and beyond can help both mother and baby avoid later obesity and cardiovascular disease. Although all women are at risk for retaining the weight gained during pregnancy, this problem is amplified for low-income, minority women. The holistic approach aims to prevent postpartum weight retention and increase breastfeeding duration with a multi-component, low-cost intervention that provides: 1) Motivational appeals delivered in text message format; 2) Environmental aides, such as a baby carrier to combine exercise with infant care, and a pedometer to accurately measure exercise at home; 3) Enhanced peer support, including home visits and group classes with other mothers; and 4) Task-oriented professional support from nutrition and lactation experts, who assist women in developing a personalized health plan. The effectiveness of the intervention will be evaluated using a randomized control methodology among clients of MCC.
- Conditions
- Obesity, Hypertension, Depression
- Being tested
- 6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes
- Keywords
- Intervention study, Maternal obesity, Nutrition, Maternal child health
- Medical subject headings
- Obesity, Hypertension, Depression, Pregnancy in Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classesBehavioural
6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes
| Study group | Role | What they receive |
|---|---|---|
| Enhanced control | No intervention | Regular care as provided by the community based organization from which the convenience sample is recruited with one year of assessments only |
| Intervention | Experimental | 6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes Receives: Behavioral: 6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum weight change
Weight difference at one year post intervention and start of intervention
Measured: Baseline and 1 year post intervention
Secondary outcomes (8)
Postpartum weight change
Weight difference at 6 months post intervention and start of intervention
Measured: Baseline and 6 months post intervention start
Depression
Using Edinburgh perinatal depression screen score, as a continuous and dichotomous (Yes/No) variable
Measured: Baseline, 6 weeks, 6 months, and 1 year post intervention start
Dietary quality
Descriptive analysis of a food log from the time points proposed
Measured: Baseline, 6 weeks, 6 months, and 1 year post intervention
Infant growth
Infant weight for length percentile at 6 weeks, 6 months, and 1 year post intervention (weight in pounds and length in inches converted to weight for length percentile using World Health Organization software support http://www.who.int/childgrowth/software/readme_stata.pdf?ua=1)
Measured: Baseline, 6 weeks, 6 months, and 1 year post intervention start
Nutrition knowledge score change
Using validated nutrition knowledge scale at 6 weeks, 6 months, and 1 year post intervention, difference from baseline
Measured: Baseline, 6 weeks, 6 months, and 1 year post intervention start
Waist circumference as continuous measure, in inches
Acquired at study assessments at the proposed time points
Measured: Baseline, 6 weeks, 6 months, and 1 year post intervention start
Back to prepregnancy weight
Dichotomous (yes/no) variable describing whether the subject returned to pre-pregnancy weight (difference between 1 year post and self-reported pre-pregnancy weight at baseline time point survey=0) or not
Measured: baseline and 1 year post intervention
Back to pregnancy weight, continuous
Continuous (difference in 1 year post-intervention weight and self-reported pre-pregnancy weight reported at baseline time point survey) variable describing the change in weight over time
Measured: baseline and 1 year postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2016
- Study completionDec 2017
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 ObesityStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, Aetna, Inc.
- Responsible party
- Principal investigator, Charmaine Smith Wright, University of Pennsylvania
- Investigators
- Charmaine Wright, MD MSHP, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867631
- Sponsor's protocol ID
- 815827
- Status last verified
- May 2019
- First submitted
- 29 May 2015
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Wright C, Mogul M, Acevedo G, Aysola J, Momplaisir F, Schwartz S, Shea J. Preparing for a trial to test a postpartum weight retention intervention among low income women: feasibility of a protocol in a community-based organization. BMC Womens Health. 2018 Jan 25;18(1):27. doi: 10.1186/s12905-018-0517-0.
PubMed 29370795
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial (RCT) of an Intervention to Combat Postpartum Weight Retention
- ClinicalTrials.gov ID
- NCT02867631
- Acronym / sponsor ID
- 815827
- Conditions
- Obesity, Hypertension, Depression
- Keywords
- Intervention study, Maternal obesity, Nutrition, Maternal child health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, Aetna, Inc.
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 16 Aug 2016 (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 Postpartum Weight Management Study is a true community-academic collaboration, bringing together Maternity Care Coalition (MCC) staff and the investigator, Dr. Charmaine Smith Wright from the University of Pennsylvania to address the needs of postpartum moms. The project is an innovative intervention to help moms lose weight after the birth of their baby. Helping mothers control their weight during pregnancy and beyond can help both mother and baby avoid later obesity and cardiovascular disease. Although all women are at risk for retaining the weight gained during pregnancy, this problem is amplified for low-income, minority women. The holistic approach aims to prevent postpartum weight retention and increase breastfeeding duration with a multi-component, low-cost intervention that provides: 1) Motivational appeals delivered in text message format; 2) Environmental aides, such as a baby carrier to combine exercise with infant care, and a pedometer to accurately measure exercise at home; 3) Enhanced peer support, including home visits and group classes with other mothers; and 4) Task-oriented professional support from nutrition and lactation experts, who assist women in developing a personalized health plan. The effectiveness of the intervention will be evaluated using a randomized control methodology among clients of MCC.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced control | No intervention | –Regular care as provided by the community based organization from which the convenience sample is recruited with one year of assessments only |
| Intervention | Experimental | Behavioral: 6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All women who speak English, and are within six weeks of delivering a live, term, single infants
Key exclusion criteria (1 listed)
- Women who have multiple births or preterm (<38 weeks gestation) infants
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 |
|---|---|---|
| 6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes | Behavioural | Intervention |
Primary outcome
Postpartum weight change
Time frame: Baseline and 1 year post intervention
Weight difference at one year post intervention and start of intervention
8 secondary outcomes
Postpartum weight change
Time frame: Baseline and 6 months post intervention start
Depression
Time frame: Baseline, 6 weeks, 6 months, and 1 year post intervention start
Dietary quality
Time frame: Baseline, 6 weeks, 6 months, and 1 year post intervention
Infant growth
Time frame: Baseline, 6 weeks, 6 months, and 1 year post intervention start
Nutrition knowledge score change
Time frame: Baseline, 6 weeks, 6 months, and 1 year post intervention start
Waist circumference as continuous measure, in inches
Time frame: Baseline, 6 weeks, 6 months, and 1 year post intervention start
Back to prepregnancy weight
Time frame: baseline and 1 year post intervention
Back to pregnancy weight, continuous
Time frame: baseline and 1 year postpartum
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 30 May 2019.
- Derived from this study: PubMed 29370795Wright C, Mogul M, Acevedo G, Aysola J, Momplaisir F, Schwartz S, Shea J. Preparing for a trial to test a postpartum weight retention intervention among low income women: feasibility of a protocol in a community-based organization. BMC Womens Health. 2018 Jan 25;18(1):27. doi: 10.1186/s12905-018-0517-0.
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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.
Charmaine Wright, MD MSHP principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes in people with Obesity and Hypertension, run by University of Pennsylvania 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 1 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 30 May 2019. 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?
Postpartum weight change (time frame: Baseline and 1 year post intervention). 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 NCT02867631, 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 30 May 2019.