Postpartum WeightEarly Phase 1FMNCT01096888
Fit Moms- an Internet-based Postpartum Weight Loss Program
A Early Phase 1 study testing Enhanced WIC Program in people with Postpartum Weight, run by California Polytechnic State University-San Luis Obispo at 1 site in United States.
Trial summary
The purpose of this study is to provide weight loss interventions for Mothers participating in the WIC program, using the internet to deliver weight loss materials. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Weight
- What is being tested?
- Enhanced WIC Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Nov 2010
- Phase
- Early Phase 1
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-35 years.
- Delivery within 6-52 weeks
- Exceed pre-pregnancy weight by at least 6.8 kg (15 pounds)
- Current BMI > 22
- English speaking
- Has computer with internet access
- Literacy of at least 5th grade reading level
Who cannot join
- Pregnant or planning to become pregnant
- Relocating in the next year
- Serious 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
1 site in 1 country.
United States1 site
California Polytechnic State University
San Luis Obispo, California, 93407
About this study
Official title: FFit Moms- an Internet-based Postpartum Weight Loss Program
The purpose of this study is to provide weight loss interventions for Mothers participating in the WIC program, using the internet to deliver weight loss materials.
Read the detailed description
Develop recruitment methods and determine feasibility of recruiting WIC postpartum women who meet inclusion criteria. We will collect data on number of individuals screened and reasons for exclusions. Establish and examine feasibility and effectiveness of protocol for WIC counselors reinforcing adherence to web based program. We will assess frequency with which WIC counselors adhere to protocol of reinforcing adherence to web-based program and extent to which any "treatment contamination" occurs between WIC counselors and Standard Care participants.In those randomized to Enhanced WIC + Internet-based postpartum program, examine acceptability, burden, ease of use, frequency of technical problems, and adherence to web-based program (number of logins, message board postings)Explore whether the Enhanced WIC plus Internet postpartum weight loss program will produce significantly greater weight losses than Standard WIC at 2 months. Explore whether Enhanced WIC plus Internet postpartum weight loss program will result in greater improvements in eating and exercise behaviors (examined at 0, and 2 months) and psychosocial parameters (i.e., depression, social support, self-efficacy, body image) than standard care.
- Conditions
- Postpartum Weight
- Being tested
- Enhanced WIC Program
- Keywords
- WIC, Weight loss, Overweight, Post Partum, Internet based weight loss intervention for Mothers in the WIC program.
- Medical subject headings
- Weight Loss, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced WIC ProgramBehavioural
Applying an internet based weight loss intervention to participants in the WIC program to enhance weight loss post partum.
| Study group | Role | What they receive |
|---|---|---|
| Standard WIC care | No intervention | Patients randomized to this group will receive standard WIC care and an information packet surround healthy eating and activity topics. |
| Enhanced WIC weight loss program | Active comparator | Participants randomized into this condition will receive standard WIC care, but will also receive weight loss classes provided through the internet. Topics will cover behavioral weight loss topics, based off the protocols of the Look AHEAD program. Receives: Behavioral: Enhanced WIC Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enhanced WIC program to instigate weight loss
We are taking the standard WIC care for Mothers who are at least 6 months post partum and enhancing their program to include an internet based weight loss intervention.
Measured: 3 months
Secondary outcomes (1)
Baseline characteristics that moderate the efficacy of the intervention.
To examine the relationship between changes in behaviors, psychosocial factors, and weight changes during the 3-month period.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum WeightStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Polytechnic State University-San Luis Obispo
- Sponsor type
- University, hospital or other
- Collaborators
- Women Infants and Children program WIC
- Responsible party
- Principal investigator, Suzanne Phelan, California Polytechnic State University-San Luis Obispo
- Investigators
- Suzanne Phelan, PhD., Principal investigator, California Polytechnic State University-San Luis Obispo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096888
- Sponsor's protocol ID
- CP-FM
- Acronym
- FM
- Status last verified
- Oct 2015
- First submitted
- 30 Mar 2010
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FFit Moms- an Internet-based Postpartum Weight Loss Program
- ClinicalTrials.gov ID
- NCT01096888
- Acronym / sponsor ID
- FM / CP-FM
- Conditions
- Postpartum Weight
- Keywords
- WIC, Weight loss, Overweight, Post Partum, Internet based weight loss intervention for Mothers in the WIC program.
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- California Polytechnic State University-San Luis ObispoUniversity, hospital or other
- Collaborators
- Women Infants and Children program WIC
- Study start
- Jun 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 31 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 provide weight loss interventions for Mothers participating in the WIC program, using the internet to deliver weight loss materials.
Detailed description
Develop recruitment methods and determine feasibility of recruiting WIC postpartum women who meet inclusion criteria. We will collect data on number of individuals screened and reasons for exclusions. Establish and examine feasibility and effectiveness of protocol for WIC counselors reinforcing adherence to web based program. We will assess frequency with which WIC counselors adhere to protocol of reinforcing adherence to web-based program and extent to which any "treatment contamination" occurs between WIC counselors and Standard Care participants.In those randomized to Enhanced WIC + Internet-based postpartum program, examine acceptability, burden, ease of use, frequency of technical problems, and adherence to web-based program (number of logins, message board postings)Explore whether the Enhanced WIC plus Internet postpartum weight loss program will produce significantly greater weight losses than Standard WIC at 2 months. Explore whether Enhanced WIC plus Internet postpartum weight loss program will result in greater improvements in eating and exercise behaviors (examined at 0, and 2 months) and psychosocial parameters (i.e., depression, social support, self-efficacy, body image) than standard care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard WIC care | No intervention | –Patients randomized to this group will receive standard WIC care and an information packet surround healthy eating and activity topics. |
| Enhanced WIC weight loss program | Active comparator | Behavioral: Enhanced WIC ProgramParticipants randomized into this condition will receive standard WIC care, but will also receive weight loss classes provided through the internet. Topics will cover behavioral weight loss topics, based off the protocols of the Look AHEAD program. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18-35 years.
- Delivery within 6-52 weeks
- Exceed pre-pregnancy weight by at least 6.8 kg (15 pounds)
- Current BMI > 22
- English speaking
Key exclusion criteria (3 listed)
- Pregnant or planning to become pregnant
- Relocating in the next year
- Serious 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 |
|---|---|---|
| Enhanced WIC ProgramApplying an internet based weight loss intervention to participants in the WIC program to enhance weight loss post partum. | Behavioural | Enhanced WIC weight loss program |
Primary outcome
Enhanced WIC program to instigate weight loss
Time frame: 3 months
We are taking the standard WIC care for Mothers who are at least 6 months post partum and enhancing their program to include an internet based weight loss intervention.
1 secondary outcome
Baseline characteristics that moderate the efficacy of the intervention.
Time frame: 3 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 28 Oct 2015.
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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.
Suzanne Phelan, PhD. principal investigator
California Polytechnic State University-San Luis Obispo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Enhanced WIC Program in people with Postpartum Weight, run by California Polytechnic State University-San Luis Obispo 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 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 28 Oct 2015. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Enhanced WIC program to instigate weight loss (time frame: 3 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 28 Oct 2015.