ObesityNCT02176915
Trial of Fresh Start Weight Loss Intervention in WIC Participants
A study testing Group program and Print Materials in people with Obesity, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The Fresh Start postpartum weight loss program will test the effectiveness of a group-based weight loss intervention that includes videos featuring peers who have successfully achieved postpartum weight loss. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Group program and Print Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Sep 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 6 months or less postpartum
- Speaks English
- BMI 25 or greater
- Client of WIC program, Worcester MA
Who cannot join
- Not able to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Fresh Start: A Randomized Clinical Trial
The Fresh Start postpartum weight loss program will test the effectiveness of a group-based weight loss intervention that includes videos featuring peers who have successfully achieved postpartum weight loss. The group-based condition will be compared to a control condition involving print materials related to weight loss.
Read the detailed description
The goal is to study the effectiveness and implementation of a postpartum weight loss intervention for WIC clients that has potential for sustainability. The investigators will compare outcomes among participants in a group-based weight loss intervention condition (Fresh Start) to outcomes among participants in a self-directed, print materials only, comparison group. The Fresh Start intervention, informed by formative research studies, consists of an 8-session group-based weight loss intervention delivered by WIC nutritionists and peer leaders. The intervention integrates key educational and skill building strategies from the lifestyle arm of the Diabetes Prevention Program with delivery strategies and messages specific for the WIC program and postpartum women. The intervention will be evaluated in a randomized clinical trial that will contribute to generalizable knowledge.
- Conditions
- Obesity
- Being tested
- Group program, Print Materials
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group programBehavioural
Print MaterialsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Group program | Experimental | 8-session group weight loss program and 4 follow-up phone counseling sessions Receives: Behavioral: Group program |
| Print Materials | Active comparator | 8 weekly mailings of print materials covering weight loss topics through US mail. Receives: Behavioral: Print Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index from baseline
Measured: 3 months, 12 months
Secondary outcomes (2)
Change in Pregnancy Physical Activity Questionnaire score from baseline
Measured: 3 months, 12 months
Change in 24-hour dietary recall from baseline
Dietary behavior will be measured using a 24-hour dietary recall.
Measured: 3 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2018
- Study completionSep 2019
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 Massachusetts, WorcesterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Stephenie Lemon, University of Massachusetts, Worcester
- Investigators
- Stephenie Lemon, PhD, Principal investigator, UMass Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176915
- Sponsor's protocol ID
- 1P60MD006912
- Other IDs
- P60MD006912
- Status last verified
- Oct 2019
- First submitted
- 25 Jun 2014
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rosal MC, Haughton CF, Estabrook BB, Wang ML, Chiriboga G, Nguyen OH, Person SD, Lemon SC. Fresh Start, a postpartum weight loss intervention for diverse low-income women: design and methods for a randomized clinical trial. BMC Public Health. 2016 Sep 9;16(1):953. doi: 10.1186/s12889-016-3520-0.
PubMed 27612615
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fresh Start: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02176915
- Acronym / sponsor ID
- 1P60MD006912
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Jul 2014
- Primary completion
- Dec 2018 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 27 Jun 2014 (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 Fresh Start postpartum weight loss program will test the effectiveness of a group-based weight loss intervention that includes videos featuring peers who have successfully achieved postpartum weight loss. The group-based condition will be compared to a control condition involving print materials related to weight loss.
Detailed description
The goal is to study the effectiveness and implementation of a postpartum weight loss intervention for WIC clients that has potential for sustainability. The investigators will compare outcomes among participants in a group-based weight loss intervention condition (Fresh Start) to outcomes among participants in a self-directed, print materials only, comparison group. The Fresh Start intervention, informed by formative research studies, consists of an 8-session group-based weight loss intervention delivered by WIC nutritionists and peer leaders. The intervention integrates key educational and skill building strategies from the lifestyle arm of the Diabetes Prevention Program with delivery strategies and messages specific for the WIC program and postpartum women. The intervention will be evaluated in a randomized clinical trial that will contribute to generalizable knowledge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group program | Experimental | Behavioral: Group program8-session group weight loss program and 4 follow-up phone counseling sessions |
| Print Materials | Active comparator | Behavioral: Print Materials8 weekly mailings of print materials covering weight loss topics through US mail. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 6 months or less postpartum
- Speaks English
- BMI 25 or greater
- Client of WIC program, Worcester MA
Key exclusion criteria (1 listed)
- Not able to give informed consent
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 |
|---|---|---|
| Group program | Behavioural | Group program |
| Print Materials | Behavioural | Print Materials |
Primary outcome
Change in Body Mass Index from baseline
Time frame: 3 months, 12 months
2 secondary outcomes
Change in Pregnancy Physical Activity Questionnaire score from baseline
Time frame: 3 months, 12 months
Change in 24-hour dietary recall from baseline
Time frame: 3 months, 12 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 14 Oct 2019.
- Derived from this study: PubMed 27612615Rosal MC, Haughton CF, Estabrook BB, Wang ML, Chiriboga G, Nguyen OH, Person SD, Lemon SC. Fresh Start, a postpartum weight loss intervention for diverse low-income women: design and methods for a randomized clinical trial. BMC Public Health. 2016 Sep 9;16(1):953. doi: 10.1186/s12889-016-3520-0.
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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.
Stephenie Lemon, PhD principal investigator
UMass Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group program and Print Materials in people with Obesity, run by University of Massachusetts, Worcester 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 4 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 14 Oct 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?
Change in Body Mass Index from baseline (time frame: 3 months, 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 NCT02176915, 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 14 Oct 2019.