ObesityPartner2LoseNCT03801174
Using Partners to Enhance Long-Term Weight Loss
A study testing Partner-assisted intervention and Patient-only intervention in people with Obesity, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study involves an evaluation of the role of domestic partner support in a comprehensive weight loss initiation and maintenance program. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Partner-assisted intervention and Patient-only intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 20 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-74 years
- BMI 27-29.9 kg/m2 plus at least one obesity-related comorbidity or BMI >=30 kg/m2
- Cohabitating and at least daily contact with a spouse/domestic partner
- Access to reliable transportation
- Desire to lose weight
- Speak and read English
Show all 21Show fewer
- Agree to attend visits per protocol
- Score of at least 4 out of 6 on Callahan cognitive screener
- Able to stand without assistance for weight measurements without assistance
- Possess individual email address
- Possess individual smart phone with data and texting plan
- Able to complete online screener without assistance
- Able to use a smartphone, tablet or computer with a video camera or webcam and microphone to download apps and to connect to a video conference call without assistance
- Aged 18 or older
- Willing to participate
- Access to reliable transportation
- Speak and read English
- Score of at least 4 out of 6 on Callahan cognitive screener
- Possess smart phone with data and texting plan (not shared with index patient)
- Possess email address (not shared with index patient)
- Able to complete online screener without assistance
Who cannot join
- Currently or planning to become pregnant or breastfeeding in the study timeframe
- Weight loss ≥ 5 lb in the month prior to screening
- Currently enrolled, or enrolled in previous 3 months, in a clinical or research program focusing on lifestyle change that could affect weight
- Significant dementia, schizophrenia, psychosis, or drug or alcohol abuse
- Chronic or unstable illness that would limit ability to participate (e.g., recent hospitalization; unstable heart disease in the 6 months prior to screening, chronic kidney disease stage 4 or higher)
- Living a nursing home or receiving visits from a home health care agency
Show all 22Show fewer
- Planning to relocate in the next 2.5 years
- Current use of prescription or over-the-counter weight loss medications
- History of bariatric surgery or planning to have bariatric surgery in the study timeframe
- Impaired hearing
- Currently receiving, or received in the past 6 months, treatment for cancer other than skin cancer
- Use of insulin, sulfonylureas, or meglinitides for diabetes
- High diuretic dose
- Exertional chest pain, dizziness, or lightheadedness
- Pain or other condition than prohibits mild-moderate exercise
- History of ascites requiring paracentesis
- BMI <18.5 kg/m2
- Significant dementia, schizophrenia, psychosis, or drug or alcohol abuse
- Residing in a nursing home or receiving home health care
- Impaired hearing
- Currently receiving, or received in the past 6 months, treatment for cancer other than skin cancer
- Chronic or unstable illness that would limit ability to participate (e.g., recent hospitalization; unstable heart disease in the 6 months prior to screening)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53705
About this study
This study involves an evaluation of the role of domestic partner support in a comprehensive weight loss initiation and maintenance program.
Read the detailed description
Couples will be randomized to a comprehensive weight program directed at patients alone or involving their partners. In months 1-6, all patients will receive group-based weight loss program. In months 7-18, all patients will receive a telephone-based weight loss maintenance intervention. In the partner-assisted arm only, partners will participate in the intervention, learning and practicing communication skills and support strategies. In months 19-24, intervention will be withdrawn to examine sustainability of effects.
Due to COVID-19, option of doing screening and outcome assessment visits and attending the group classes (including exercise) remotely via a video conference may be available. COVID-19 survey will be administered every 3 month starting at screening/enrollment visit.
- Conditions
- Obesity
- Being tested
- Partner-assisted intervention, Patient-only intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partner-assisted interventionBehavioural
All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Partners will attend some patient group sessions and be informed of patients' goals and relapse plans. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.
Patient-only interventionBehavioural
All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.
| Study group | Role | What they receive |
|---|---|---|
| Partner-assisted intervention | Experimental | Patients and partners will receive intervention Receives: Behavioral: Partner-assisted intervention |
| Patient-only intervention | Active comparator | Patients will receive intervention Receives: Behavioral: Patient-only intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight (kg)
Measured on a calibrated, digital scale to the nearest 0.1 kg, assessed every 6 months with 24 months as primary endpoint
Measured: 24 months
Secondary outcomes (2)
Caloric Intake (kcal)
average estimated daily intake from ASA24 Dietary Assessment Tool, assessed every 6 months with 24 months as primary endpoint
Measured: 24 months
Physical Activity
average daily steps over past 7 days from Fitbit, assessed every 6 months with 24 months as primary endpoint
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start15 Jan 2019
- Primary completion14 Mar 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, RTI International, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Corrine Voils, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801174
- Sponsor's protocol ID
- 2018-1400
- Other IDs
- 1R01DK111491-01A1, A539722, SMPH/SURGERY, 2018-1400-CP028
- Acronym
- Partner2Lose
- Status last verified
- May 2024
- First submitted
- 3 Jan 2019
- Last updated
- 6 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gray KE, Porter LS, Shaw RJ, Gavin KL, Hetzel SJ, Lewis MA, Pabich S, Johnson HM, Elwert F, Mao L, Garza K, Yancy WS Jr, Voils CI. Partner Weight Loss and Diet Outcomes at 24 Months in a Randomized Controlled Trial of a Dyadic Versus Individual Weight Management Intervention. Obes Sci Pract. 2026 Aug 12;12(4):e70178. doi: 10.1002/osp4.70178. eCollection 2026 Aug.
PubMed 42592072Voils CI, Shaw RJ, Gavin KL, Hetzel SJ, Lewis MA, Pabich S, Johnson HM, Elwert F, Mao L, Gray KE, Yuroff A, Garza K, Yancy WS Jr, Porter LS. Outcomes from Partner2Lose: a randomized controlled trial to evaluate 24-month weight loss in a partner-assisted intervention. BMC Public Health. 2024 Jul 20;24(1):1948. doi: 10.1186/s12889-024-19464-z.
PubMed 39033273Voils C, Shaw R, Gavin K, Hetzel S, Lewis M, Pabich S, Johnson H, Elwert F, Mao L, Gray K, Yuroff A, Garza K, Yancy W, Porter L. Primary outcomes from Partner2Lose: A randomized controlled trial to evaluate partner involvement on long-term weight loss. Res Sq [Preprint]. 2024 Mar 11:rs.3.rs-4001003. doi: 10.21203/rs.3.rs-4001003/v1.
PubMed 38559225Miller HN, Voils CI, Cronin KA, Jeanes E, Hawley J, Porter LS, Adler RR, Sharp W, Pabich S, Gavin KL, Lewis MA, Johnson HM, Yancy WS Jr, Gray KE, Shaw RJ. A Method to Deliver Automated and Tailored Intervention Content: 24-month Clinical Trial. JMIR Form Res. 2022 Sep 6;6(9):e38262. doi: 10.2196/38262.
PubMed 36066936Voils CI, Shaw R, Adler R, Jeanes E, Lewis MA, Sharp W, Cronin KA, Hetzel S, Mao L, Johnson HM, Elwert F, Pabich S, Gavin KL, Yancy WS Jr, Porter LS. Protocol for Partner2Lose: A randomized controlled trial to evaluate partner involvement on long-term weight loss. Contemp Clin Trials. 2020 Sep;96:106092. doi: 10.1016/j.cct.2020.106092. Epub 2020 Aug 1.
PubMed 32750431
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Partners to Enhance Long-Term Weight Loss
- ClinicalTrials.gov ID
- NCT03801174
- Acronym / sponsor ID
- Partner2Lose / 2018-1400
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Duke University, RTI International, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 11 Jan 2019 (actual)
- Results
- Posted 6 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study involves an evaluation of the role of domestic partner support in a comprehensive weight loss initiation and maintenance program.
Detailed description
Couples will be randomized to a comprehensive weight program directed at patients alone or involving their partners. In months 1-6, all patients will receive group-based weight loss program. In months 7-18, all patients will receive a telephone-based weight loss maintenance intervention. In the partner-assisted arm only, partners will participate in the intervention, learning and practicing communication skills and support strategies. In months 19-24, intervention will be withdrawn to examine sustainability of effects.
Due to COVID-19, option of doing screening and outcome assessment visits and attending the group classes (including exercise) remotely via a video conference may be available. COVID-19 survey will be administered every 3 month starting at screening/enrollment visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partner-assisted intervention | Experimental | Behavioral: Partner-assisted interventionPatients and partners will receive intervention |
| Patient-only intervention | Active comparator | Behavioral: Patient-only interventionPatients will receive intervention |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Aged 18-74 years
- BMI 27-29.9 kg/m2 plus at least one obesity-related comorbidity or BMI >=30 kg/m2
- Cohabitating and at least daily contact with a spouse/domestic partner
- Access to reliable transportation
- Desire to lose weight
Key exclusion criteria (22 listed)
- Currently or planning to become pregnant or breastfeeding in the study timeframe
- Weight loss ≥ 5 lb in the month prior to screening
- Currently enrolled, or enrolled in previous 3 months, in a clinical or research program focusing on lifestyle change that could affect weight
- Significant dementia, schizophrenia, psychosis, or drug or alcohol abuse
- Chronic or unstable illness that would limit ability to participate (e.g., recent hospitalization; unstable heart disease in the 6 months prior to screening, chronic kidney disease stage 4 or higher)
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 |
|---|---|---|
| Partner-assisted interventionAll patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Partners will attend some patient group sessions and be informed of patients' goals and relapse plans. Intervention will be withdrawn for the last 6 months to examine sustainability of effects. | Behavioural | Partner-assisted intervention |
| Patient-only interventionAll patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Intervention will be withdrawn for the last 6 months to examine sustainability of effects. | Behavioural | Patient-only intervention |
Primary outcome
Body Weight (kg)
Time frame: 24 months
Measured on a calibrated, digital scale to the nearest 0.1 kg, assessed every 6 months with 24 months as primary endpoint
2 secondary outcomes
Caloric Intake (kcal)
Time frame: 24 months
Physical Activity
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42592072Gray KE, Porter LS, Shaw RJ, Gavin KL, Hetzel SJ, Lewis MA, Pabich S, Johnson HM, Elwert F, Mao L, Garza K, Yancy WS Jr, Voils CI. Partner Weight Loss and Diet Outcomes at 24 Months in a Randomized Controlled Trial of a Dyadic Versus Individual Weight Management Intervention. Obes Sci Pract. 2026 Aug 12;12(4):e70178. doi: 10.1002/osp4.70178. eCollection 2026 Aug.
- Derived from this study: PubMed 39033273Voils CI, Shaw RJ, Gavin KL, Hetzel SJ, Lewis MA, Pabich S, Johnson HM, Elwert F, Mao L, Gray KE, Yuroff A, Garza K, Yancy WS Jr, Porter LS. Outcomes from Partner2Lose: a randomized controlled trial to evaluate 24-month weight loss in a partner-assisted intervention. BMC Public Health. 2024 Jul 20;24(1):1948. doi: 10.1186/s12889-024-19464-z.
- Derived from this study: PubMed 38559225Voils C, Shaw R, Gavin K, Hetzel S, Lewis M, Pabich S, Johnson H, Elwert F, Mao L, Gray K, Yuroff A, Garza K, Yancy W, Porter L. Primary outcomes from Partner2Lose: A randomized controlled trial to evaluate partner involvement on long-term weight loss. Res Sq [Preprint]. 2024 Mar 11:rs.3.rs-4001003. doi: 10.21203/rs.3.rs-4001003/v1.
- Derived from this study: PubMed 36066936Miller HN, Voils CI, Cronin KA, Jeanes E, Hawley J, Porter LS, Adler RR, Sharp W, Pabich S, Gavin KL, Lewis MA, Johnson HM, Yancy WS Jr, Gray KE, Shaw RJ. A Method to Deliver Automated and Tailored Intervention Content: 24-month Clinical Trial. JMIR Form Res. 2022 Sep 6;6(9):e38262. doi: 10.2196/38262.
- Derived from this study: PubMed 32750431Voils CI, Shaw R, Adler R, Jeanes E, Lewis MA, Sharp W, Cronin KA, Hetzel S, Mao L, Johnson HM, Elwert F, Pabich S, Gavin KL, Yancy WS Jr, Porter LS. Protocol for Partner2Lose: A randomized controlled trial to evaluate partner involvement on long-term weight loss. Contemp Clin Trials. 2020 Sep;96:106092. doi: 10.1016/j.cct.2020.106092. Epub 2020 Aug 1.
- Partner2Lose websiteLink provided by the sponsor.
- 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.
Corrine Voils, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partner-assisted intervention and Patient-only intervention in people with Obesity, run by University of Wisconsin, Madison 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 21 inclusion and 22 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 6 Jun 2024. 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?
Yes. Results are posted in the registry (first posted 6 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Body Weight (kg) (time frame: 24 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 NCT03801174, which also lists 5 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 6 Jun 2024.