Overweight and ObesityNCT03042208
Weight Watchers and Families
A study testing Self guided handout and Weight Watchers in people with Overweight and Obesity, run by University of Connecticut.
Trial summary
Research suggests that when one spouse loses weight, the other spouse does too. This study will examine whether a ripple effect is observed in untreated spouses and children of individuals participating in a nationally available weight loss program. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Self guided handout and Weight Watchers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2015to 30 Oct 2015
- 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- body mass index between 27.0-40.0 kg/m2
- married or living with a significant other who had a BMI > 25 kg/m2
Who cannot join
- currently in a weight loss program, dieting, or taking medications that might affect weight
- had participated in a weight loss program in the past year
- lost > 5% of their body weight in the past 6 months
- were planning to or had undergone weight loss surgery
- had any orthopedic limitations or contraindications to physical activity
- were pregnant, lactating, or less than 6 months postpartum, or were planning to become pregnant in the next year
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- reported uncontrolled hypertension, history of coronary heart disease, stroke, or peripheral arterial disease; reported chronic gastrointestinal disease
- endorsed having hepatitis B or C, cirrhosis, or HIV
- had a history of cancer within the past 5 years
- reported a significant psychiatric illness that might interfere with completion of the study.
About this study
Official title: Ripple Effect of a Nationally Available Weight Loss Program on Untreated Family Members
Research suggests that when one spouse loses weight, the other spouse does too. This study will examine whether a ripple effect is observed in untreated spouses and children of individuals participating in a nationally available weight loss program. Participants will be randomly assigned to either receive Weight Watchers immediately or at the end of a 6-month waiting period. Participants and untreated spouses (and any children in the home) will be assessed at baseline, 3, and 6 months.
- Conditions
- Overweight and Obesity
- Being tested
- Self guided handout, Weight Watchers
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self guided handoutOther
Written handout with basic weight management strategies
Weight WatchersBehavioural
Access to Weight Watchers in-person meetings and online tools
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Access to Weight Watchers in-person meetings and online tools. Receives: Behavioral: Weight Watchers |
| Self-Guided Control Group | Other | Received handout with basic weight management advice. Receives: Other: Self guided handout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
body weight measured in kg
Measured: 0, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start2 Jan 2015
- Primary completion30 Oct 2015
- Study completion30 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overweight and 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- WW International Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042208
- Sponsor's protocol ID
- H14-260
- Status last verified
- Feb 2017
- First submitted
- 31 Jan 2017
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McManus-Shipp KE, Cornelius T, Wojtanowski AC, Leahey T, Foster GD, Gorin AA. Family functioning and the implications for adult weight management. Fam Syst Health. 2025 Mar;43(1):157-161. doi: 10.1037/fsh0000929. Epub 2024 Sep 16.
PubMed 39283252Gorin AA, Lenz EM, Cornelius T, Huedo-Medina T, Wojtanowski AC, Foster GD. Randomized Controlled Trial Examining the Ripple Effect of a Nationally Available Weight Management Program on Untreated Spouses. Obesity (Silver Spring). 2018 Mar;26(3):499-504. doi: 10.1002/oby.22098. Epub 2018 Feb 1.
PubMed 29388385
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ripple Effect of a Nationally Available Weight Loss Program on Untreated Family Members
- ClinicalTrials.gov ID
- NCT03042208
- Acronym / sponsor ID
- H14-260
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- WW International Inc
- Study start
- 2 Jan 2015 (actual)
- Primary completion
- 30 Oct 2015 (actual)
- Study completion
- 30 Oct 2015 (actual)
- First posted
- 3 Feb 2017 (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.
Research suggests that when one spouse loses weight, the other spouse does too. This study will examine whether a ripple effect is observed in untreated spouses and children of individuals participating in a nationally available weight loss program. Participants will be randomly assigned to either receive Weight Watchers immediately or at the end of a 6-month waiting period. Participants and untreated spouses (and any children in the home) will be assessed at baseline, 3, and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Weight WatchersAccess to Weight Watchers in-person meetings and online tools. |
| Self-Guided Control Group | Other | Other: Self guided handoutReceived handout with basic weight management advice. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- body mass index between 27.0-40.0 kg/m2
- married or living with a significant other who had a BMI > 25 kg/m2
Key exclusion criteria (10 listed)
- currently in a weight loss program, dieting, or taking medications that might affect weight
- had participated in a weight loss program in the past year
- lost > 5% of their body weight in the past 6 months
- were planning to or had undergone weight loss surgery
- had any orthopedic limitations or contraindications to physical activity
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 |
|---|---|---|
| Self guided handoutWritten handout with basic weight management strategies | Other | Self-Guided Control Group |
| Weight WatchersAccess to Weight Watchers in-person meetings and online tools | Behavioural | Intervention |
Primary outcome
Change in Weight
Time frame: 0, 3, and 6 months
body weight measured in kg
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 3 Feb 2017.
- Derived from this study: PubMed 39283252McManus-Shipp KE, Cornelius T, Wojtanowski AC, Leahey T, Foster GD, Gorin AA. Family functioning and the implications for adult weight management. Fam Syst Health. 2025 Mar;43(1):157-161. doi: 10.1037/fsh0000929. Epub 2024 Sep 16.
- Derived from this study: PubMed 29388385Gorin AA, Lenz EM, Cornelius T, Huedo-Medina T, Wojtanowski AC, Foster GD. Randomized Controlled Trial Examining the Ripple Effect of a Nationally Available Weight Management Program on Untreated Spouses. Obesity (Silver Spring). 2018 Mar;26(3):499-504. doi: 10.1002/oby.22098. Epub 2018 Feb 1.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Self guided handout and Weight Watchers in people with Overweight and Obesity, run by University of Connecticut.
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 2 inclusion and 10 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 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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 (time frame: 0, 3, and 6 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 NCT03042208, which also lists 2 linked publications.
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 3 Feb 2017.