ObesityNCT01770028
Ripple Effect of Lifestyle Intervention During Pregnancy on Partners' Weight
An observational study of Obesity, run by California Polytechnic State University-San Luis Obispo at 3 sites in United States.
Trial summary
The primary aim of the proposed study is to determine whether lifestyle interventions to prevent excessive gestational weight gain in overweight/obese pregnant women have positive "ripple" effects on untreated partners in the home. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 122 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2013to Jul 2017
- How long will I take part?
- 19 Months
- 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: This study uses a randomized repeated measures design. Partners will be categorized based on randomized status of their pregnant partner (in the parent grants; NIH 1U01HL114377-01, PI Phelan; NIH 3U01DK094418-01S1, PIs Redman and Martin). Partner participation in the ancillary study will not be mandatory for participation in the parent grant. NOTE: There is no intervention in partners.
Who may be able to join
- Man or woman who self-identifies as sharing an intimate relationship and cohabitating in the home with the pregnant women (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/assent
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Columbia University
New York, New York, 10027
Miriam Hospital
Providence, Rhode Island, 02906
California Polytechnic State University
San Luis Obispo, California, 93407
About this study
The primary aim of the proposed study is to determine whether lifestyle interventions to prevent excessive gestational weight gain in overweight/obese pregnant women have positive "ripple" effects on untreated partners in the home. We hypothesize that partners of pregnant women randomized to the lifestyle intervention, relative to those of standard care, will have greater weight losses through 12-months. Secondary aims examine partner improvements in weight control behaviors, the home environment, and psychosocial parameters.
Read the detailed description
Lifestyle interventions targeting overweight 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 prenatal lifestyle interventions that target mothers' gestational weight gain. The primary aim of the proposed study is to determine whether lifestyle interventions to prevent excessive gestational weight gain in overweight/obese pregnant women have positive "ripple" effects on untreated partners in the home. The proposed study is ancillary to two randomized phase III clinical trials in the LIFE-moms consortium (1U01HL114377-01, PI Phelan; 3U01DK094463-03S1, PIs Pi-Sunyer and Gallagher) that are examining the efficacy of multi-component lifestyle interventions to prevent excessive gestational weight gain in a total of 650 overweight/obese women. In this ancillary study, partners' weight, home environment, and psychosocial behaviors will be assessed when their pregnant partners are ~13 weeks gestation (study entry), 35 weeks gestation and at 6 and 12 months postpartum. We hypothesize that partners of pregnant women randomized to the lifestyle intervention, relative to those of standard care, will have greater weight losses through 12-months. Secondary aims examine partner improvements in weight control behaviors, the home environment, and psychosocial parameters. This project is highly innovative, as it capitalizes on existing funded research and is the first study to examine ripple effects of multicomponent prenatal interventions. The project also has high impact, as pregnancy 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 interventions to prevent excessive gestational weight gain have positive "ripple" effects on the health of untreated partners in the home.
- Conditions
- Obesity
- Keywords
- Obesity, Pregnancy, Spouse, Weight loss, Behavioral
- Medical subject headings
- Obesity, Weight Loss, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intervention partners | Partners of pregnant women randomized to lifestyle intervention. Note: There is no intervention in partners of pregnant women. | |
| Standard care partners | Partners of pregnant women randomized to Standard Care. Note: There is no intervention in partners of pregnant women. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight of partners of pregnant women
Change in weight of partners of pregnant women randomized to the lifestyle intervention, relative to partners of pregnant women of standard care, from 13 weeks gestation to 35 weeks gestation and 6 and 12-months postpartum.
Measured: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
Secondary outcomes (8)
Percent of partners with weight change loss >5%, 10%, and 15%
Measured: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
Change in calorie and fat intake
Measured: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
Change in physical activity levels
Measured: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
Change in sleep patterns and sleep hours
Measured: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
Change in self-monitoring
Measured: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
Change in food, exercise and sedentary cues in the home environment
Measured: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
Change in mood
Measured: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
Change in dietary restraint
Measured: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2017
- Study completionJul 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.
- 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
- 122 participants (actual)
- Target duration
- 19 Months
Sponsor and investigators
- Lead sponsor
- California Polytechnic State University-San Luis Obispo
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, Columbia University
- Responsible party
- Principal investigator, Todd Hagobian, California Polytechnic State University-San Luis Obispo
- Investigators
- Todd A Hagobian, PhD, Principal investigator, California Polytechnic State University-San Luis Obispo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770028
- Sponsor's protocol ID
- 1R01HL118208
- Status last verified
- Feb 2018
- First submitted
- 8 Jan 2013
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hagobian TA, Phelan S, Schaffner A, Brannen A, McHugh A, Ashby-Thompson M, Gorin AA, Pi-Sunyer X, Gallagher D, Wing R. Ripple Effect of Lifestyle Interventions During Pregnancy on Untreated Partners' Weight. Obesity (Silver Spring). 2019 May;27(5):733-739. doi: 10.1002/oby.22447. Epub 2019 Apr 8.
PubMed 30957985
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ripple Effect of Lifestyle Intervention During Pregnancy on Partners' Weight
- ClinicalTrials.gov ID
- NCT01770028
- Acronym / sponsor ID
- 1R01HL118208
- Conditions
- Obesity
- Keywords
- Obesity, Pregnancy, Spouse, Weight loss, Behavioral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- California Polytechnic State University-San Luis ObispoUniversity, hospital or other
- Collaborators
- Brown University, Columbia University
- Study start
- Jan 2013
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 17 Jan 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 primary aim of the proposed study is to determine whether lifestyle interventions to prevent excessive gestational weight gain in overweight/obese pregnant women have positive "ripple" effects on untreated partners in the home. We hypothesize that partners of pregnant women randomized to the lifestyle intervention, relative to those of standard care, will have greater weight losses through 12-months. Secondary aims examine partner improvements in weight control behaviors, the home environment, and psychosocial parameters.
Detailed description
Lifestyle interventions targeting overweight 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 prenatal lifestyle interventions that target mothers' gestational weight gain. The primary aim of the proposed study is to determine whether lifestyle interventions to prevent excessive gestational weight gain in overweight/obese pregnant women have positive "ripple" effects on untreated partners in the home. The proposed study is ancillary to two randomized phase III clinical trials in the LIFE-moms consortium (1U01HL114377-01, PI Phelan; 3U01DK094463-03S1, PIs Pi-Sunyer and Gallagher) that are examining the efficacy of multi-component lifestyle interventions to prevent excessive gestational weight gain in a total of 650 overweight/obese women. In this ancillary study, partners' weight, home environment, and psychosocial behaviors will be assessed when their pregnant partners are ~13 weeks gestation (study entry), 35 weeks gestation and at 6 and 12 months postpartum. We hypothesize that partners of pregnant women randomized to the lifestyle intervention, relative to those of standard care, will have greater weight losses through 12-months. Secondary aims examine partner improvements in weight control behaviors, the home environment, and psychosocial parameters. This project is highly innovative, as it capitalizes on existing funded research and is the first study to examine ripple effects of multicomponent prenatal interventions. The project also has high impact, as pregnancy 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 interventions to prevent excessive gestational weight gain have positive "ripple" effects on the health of untreated partners in the home.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 19 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention partners | – | –Partners of pregnant women randomized to lifestyle intervention. Note: There is no intervention in partners of pregnant women. |
| Standard care partners | – | –Partners of pregnant women randomized to Standard Care. Note: There is no intervention in partners of pregnant women. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study uses a randomized repeated measures design. Partners will be categorized based on randomized status of their pregnant partner (in the parent grants; NIH 1U01HL114377-01, PI Phelan; NIH 3U01DK094418-01S1, PIs Redman and Martin). Partner participation in the ancillary study will not be mandatory for participation in the parent grant. NOTE: There is no intervention in partners.
Key inclusion criteria (3 listed)
- Man or woman who self-identifies as sharing an intimate relationship and cohabitating in the home with the pregnant women (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/assent
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.
Primary outcome
Change in weight of partners of pregnant women
Time frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
Change in weight of partners of pregnant women randomized to the lifestyle intervention, relative to partners of pregnant women of standard care, from 13 weeks gestation to 35 weeks gestation and 6 and 12-months postpartum.
8 secondary outcomes
Percent of partners with weight change loss >5%, 10%, and 15%
Time frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
Change in calorie and fat intake
Time frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
Change in physical activity levels
Time frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
Change in sleep patterns and sleep hours
Time frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
Change in self-monitoring
Time frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
Change in food, exercise and sedentary cues in the home environment
Time frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
Change in mood
Time frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
Change in dietary restraint
Time frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months 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 12 Feb 2018.
- Derived from this study: PubMed 30957985Hagobian TA, Phelan S, Schaffner A, Brannen A, McHugh A, Ashby-Thompson M, Gorin AA, Pi-Sunyer X, Gallagher D, Wing R. Ripple Effect of Lifestyle Interventions During Pregnancy on Untreated Partners' Weight. Obesity (Silver Spring). 2019 May;27(5):733-739. doi: 10.1002/oby.22447. Epub 2019 Apr 8.
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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 A Hagobian, PhD principal investigator
California Polytechnic State University-San Luis Obispo
3 sites 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 3 sites 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 12 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 3 sites 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 weight of partners of pregnant women (time frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum). 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 NCT01770028, 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 12 Feb 2018.