ObesityNCT01921959
Fit Moms in Partners, Children, and Other Members
An observational study of Obesity, run by California Polytechnic State University-San Luis Obispo at 1 site in United States.
Trial summary
The purpose of this ancillary study is to determine whether a behavioral weight loss intervention for postpartum mothers (5R01DK087889-02, PI Phelan; Co-I Tate) has a positive "ripple" effect on weight and health of partners and children/offspring. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2013to 1 Aug 2017
- Phase
- Observational
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Partners of postpartum women
Who may be able to join
- Man or woman who self-identifies as sharing an intimate relationship and cohabitating in the home with the postpartum woman (enrolled in the parent grant) for the previous 3 months or recently been married and living in the home
- ≥18 years
- willing to provide informed consent
Who cannot join
- None
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: Effects of Postpartum Weight Loss Intervention on Partner and Offspring Weight
The purpose of this ancillary study is to determine whether a behavioral weight loss intervention for postpartum mothers (5R01DK087889-02, PI Phelan; Co-I Tate) has a positive "ripple" effect on weight and health of partners and children/offspring.
Read the detailed description
Lifestyle interventions targeting overweight/obese individuals can produce positive "ripple" effects on untreated overweight partners in the home. Interestingly, ripple effects on partners' weight appear most pronounced when the interventions target women. Women, and mothers in particular, remain the primary "nutritional gatekeepers" of the home. Despite widespread recognition that motherhood is a powerful motivator for behavior changes, no study to date has examined the "ripple" effects of a postpartum Internet-based lifestyle intervention that target mothers' weight. The purpose of this ancillary study is to determine whether a behavioral weight loss intervention for postpartum mothers (5R01DK087889-02, PI Phelan; Co-I Tate) has a positive "ripple" effect on weight and health of partners and children/offspring. The proposed study is ancillary to an ongoing clinic-randomized trial examining the efficacy of an innovative multicomponent (online, face-to-face, mobile phone) postpartum behavioral weight loss intervention in 408 low-income women in the Women, Infants, and Children program. The proposed study will determine whether partners of women randomized to the postpartum BWL intervention have greater weight losses and greater improvements in health outcomes than partners of women in standard WIC. Similar to the parent grant, assessments will occur at study entry, 6 months, and 12 months. This project is highly innovative, as it capitalizes on existing funded research and is the first study to examine ripple effects of multicomponent Internet-based intervention in low-income individuals. The project also has high impact, as the postpartum period is a powerful motivator for behavior and environmental changes in the home; and, if positive ripple effects occur, the field of obesity treatment and prevention could move beyond focus on individual level to the often, unrecognized interpersonal effects of lifestyle interventions. PUBLIC HEALTH RELEVANCE: This research project will examine whether a postpartum weight-loss intervention has a positive "ripple" effects on weight and health of untreated partners and offspring/children in the home.
- Conditions
- Obesity
- Being tested
- Intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Postpartum women are randomized to intervention or control group
| Study group | Role | What they receive |
|---|---|---|
| Partners of intervention women | Partners of women randomized to intervention Receives: Behavioral: Intervention | |
| Partners of no intervention women | Partners of women randomized to control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight and Weight Change
Absolute weight and change in weight
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study start1 Aug 2013
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Polytechnic State University-San Luis Obispo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Todd Hagobian, California Polytechnic State University-San Luis Obispo
- Investigators
- Todd Hagobian, PhD, Principal investigator, Cal Poly San Luis Obispo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921959
- Sponsor's protocol ID
- RDK101926A
- Status last verified
- Feb 2018
- First submitted
- 9 Aug 2013
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Postpartum Weight Loss Intervention on Partner and Offspring Weight
- ClinicalTrials.gov ID
- NCT01921959
- Acronym / sponsor ID
- RDK101926A
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- California Polytechnic State University-San Luis ObispoUniversity, hospital or other
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 14 Aug 2013 (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 ancillary study is to determine whether a behavioral weight loss intervention for postpartum mothers (5R01DK087889-02, PI Phelan; Co-I Tate) has a positive "ripple" effect on weight and health of partners and children/offspring.
Detailed description
Lifestyle interventions targeting overweight/obese individuals can produce positive "ripple" effects on untreated overweight partners in the home. Interestingly, ripple effects on partners' weight appear most pronounced when the interventions target women. Women, and mothers in particular, remain the primary "nutritional gatekeepers" of the home. Despite widespread recognition that motherhood is a powerful motivator for behavior changes, no study to date has examined the "ripple" effects of a postpartum Internet-based lifestyle intervention that target mothers' weight. The purpose of this ancillary study is to determine whether a behavioral weight loss intervention for postpartum mothers (5R01DK087889-02, PI Phelan; Co-I Tate) has a positive "ripple" effect on weight and health of partners and children/offspring. The proposed study is ancillary to an ongoing clinic-randomized trial examining the efficacy of an innovative multicomponent (online, face-to-face, mobile phone) postpartum behavioral weight loss intervention in 408 low-income women in the Women, Infants, and Children program. The proposed study will determine whether partners of women randomized to the postpartum BWL intervention have greater weight losses and greater improvements in health outcomes than partners of women in standard WIC. Similar to the parent grant, assessments will occur at study entry, 6 months, and 12 months. This project is highly innovative, as it capitalizes on existing funded research and is the first study to examine ripple effects of multicomponent Internet-based intervention in low-income individuals. The project also has high impact, as the postpartum period is a powerful motivator for behavior and environmental changes in the home; and, if positive ripple effects occur, the field of obesity treatment and prevention could move beyond focus on individual level to the often, unrecognized interpersonal effects of lifestyle interventions. PUBLIC HEALTH RELEVANCE: This research project will examine whether a postpartum weight-loss intervention has a positive "ripple" effects on weight and health of untreated partners and offspring/children in the home.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partners of intervention women | – | Behavioral: InterventionPartners of women randomized to intervention |
| Partners of no intervention women | – | –Partners of women randomized to control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Partners of postpartum women
Key inclusion criteria (3 listed)
- Man or woman who self-identifies as sharing an intimate relationship and cohabitating in the home with the postpartum woman (enrolled in the parent grant) for the previous 3 months or recently been married and living in the home
- ≥18 years
- willing to provide informed consent
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| InterventionPostpartum women are randomized to intervention or control group | Behavioural | Partners of intervention women |
Primary outcome
Weight and Weight Change
Time frame: 12 months
Absolute weight and change in weight
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 Feb 2018.
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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.
Todd Hagobian, PhD principal investigator
Cal Poly San Luis Obispo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, 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 3 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 Feb 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 and Weight Change (time frame: 12 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 Feb 2018; AzTrials last refreshed its copy on 7 Nov 2026.