Obesity
Conditions
Brief summary
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 In months 19-24, intervention will be withdrawn to examine sustainability of effects.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.
Interventions
BEHAVIORALPartner-assisted intervention
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 Intervention will be withdrawn for the last 6 months to examine sustainability of effects.
BEHAVIORALPatient-only intervention
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 Intervention will be withdrawn for the last 6 months to examine sustainability of effects.
Sponsors
Duke University
RTI International
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
Yes
Inclusion criteria
(patients): * 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 * 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
Exclusion criteria
(patients): * 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 * 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 Inclusion criteria (partner): * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight (kg) | 24 months | Measured on a calibrated, digital scale to the nearest 0.1 kg, assessed every 6 months with 24 months as primary endpoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caloric Intake (kcal) | 24 months | average estimated daily intake from ASA24 Dietary Assessment Tool, assessed every 6 months with 24 months as primary endpoint |
| Physical Activity | 24 months | average daily steps over past 7 days from Fitbit, assessed every 6 months with 24 months as primary endpoint |
Other
| Measure | Time frame | Description |
|---|---|---|
| Social Support for Diet | 3 months | 9 items assessed on 5-point scale (never, rarely, sometimes, often, almost always) |
| Use of Communal Coping Strategies for Diet | 3 months | 5 items assessed on 5-point frequency scale (never, sometimes, frequently, often, very often) |
| Transformation of Motivation for Physical Activity | 3 months | Score based on 12-item Unidimensional Relationship Closeness Scale (1-7, strongly disagree to strongly agree) and single-item Inclusion of Other in Self scale (7 Venn diagrams) |
| Transformation of Motivation for Diet | 3 months | Score based on 12-item Unidimensional Relationship Closeness Scale (1-7, strongly disagree to strongly agree) and single-item Inclusion of Other in Self scale (7 Venn diagrams) |
| Couple Efficacy for Physical Activity | 3 months | 5 items assessed on 11-point scale ranging from 0 (not at all confident) to 10 (very confident) |
| Social Support for Physical Activity | 3 months | 9 items assessed on 5-point scale (never, rarely, sometimes, often, almost always) |
| Use of Communal Coping Strategies for Physical Activity | 3 months | 5 items assessed on 5-point frequency scale (never, sometimes, frequently, often, very often) |
| Outcome Efficacy for Physical Activity | 3 months | 5 items assessed on 11-point scale ranging from 0 (not at all effective) to 10 (very effective) |
| Outcome Efficacy for Diet | 3 months | 5 items assessed on 11-point scale ranging from 0 (not at all effective) to 10 (very effective) |
| Couple Efficacy for Diet | 3 months | 5 items assessed on 11-point scale ranging from 0 (not at all confident) to 10 (very confident) |
Countries
United States
Participant flow
Recruitment details
Enrollment numbers reflect only patients, not dyads, as this is how the study analysis was powered.
Pre-assignment details
Enrollment numbers reflect only patients, not dyads. Partners were not assessed and therefore are not their own arm. Partners were not considered as enrolled, and are not included in the reported enrollment number. Partners did not have Baseline, pre-specified Primary and/or Secondary Outcome Measure, and Adverse Event data collected.
Participants by arm
| Arm | Count |
|---|---|
| Partner-assisted Intervention: Patient Patients and partners will receive intervention
Partner-assisted intervention: 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. | 115 |
| Patient-only Intervention Patients will receive intervention
Patient-only intervention: 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. | 116 |
| Total | 231 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lack of Efficacy | 4 | 0 |
| Overall Study | Lost to Follow-up | 19 | 10 |
| Overall Study | Moved out of area | 3 | 0 |
| Overall Study | Other | 4 | 3 |
| Overall Study | Pregnancy | 2 | 2 |
| Overall Study | Unwilling to complete activities | 5 | 6 |
| Overall Study | Withdrawal by Subject | 14 | 15 |
Baseline characteristics
| Characteristic | Partner-assisted Intervention: Patient | Total | Patient-only Intervention |
|---|---|---|---|
| Age, Continuous Participant | 47.3 years STANDARD_DEVIATION 11.31 | 47.27 years STANDARD_DEVIATION 11.51 | 47.24 years STANDARD_DEVIATION 11.76 |
| Body weight | 106.20 kilograms STANDARD_DEVIATION 19.03 | 106.55 kilograms STANDARD_DEVIATION 19.41 | 106.90 kilograms STANDARD_DEVIATION 19.84 |
| Daily caloric intake | 2182.66 kcal/day STANDARD_DEVIATION 730 | 2142.88 kcal/day STANDARD_DEVIATION 733.43 | 2103.10 kcal/day STANDARD_DEVIATION 737.88 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 10 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 108 Participants | 220 Participants | 112 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 12 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 97 Participants | 198 Participants | 101 Participants |
| Region of Enrollment United States | 115 participants | 231 participants | 116 participants |
| Sex/Gender, Customized Birth sex - Female | 78 participants | 157 participants | 79 participants |
| Sex/Gender, Customized Genderqueer | 1 participants | 1 participants | 0 participants |
| Sex/Gender, Customized Identify as Female | 76 participants | 155 participants | 79 participants |
| Sex/Gender, Customized Identify as Male | 37 participants | 74 participants | 37 participants |
| Sex/Gender, Customized Multi-gender | 1 participants | 1 participants | 0 participants |
| Steps per day | 8023.37 steps/day STANDARD_DEVIATION 3412.32 | 8114.40 steps/day STANDARD_DEVIATION 3512.68 | 8203.70 steps/day STANDARD_DEVIATION 3622.56 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 115 | 0 / 116 |
| other Total, other adverse events | 55 / 115 | 52 / 116 |
| serious Total, serious adverse events | 3 / 115 | 3 / 116 |
Outcome results
Primary
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
Time frame: 24 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Partner-assisted Intervention | Body Weight (kg) | 104.46 kilograms |
| Patient-only Intervention | Body Weight (kg) | 104.23 kilograms |
p-value: 0.80495% CI: [-2, 1.6]Mixed Models Analysis
Secondary
Caloric Intake (kcal)
average estimated daily intake from ASA24 Dietary Assessment Tool, assessed every 6 months with 24 months as primary endpoint
Time frame: 24 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Partner-assisted Intervention | Caloric Intake (kcal) | 1835 KCALs/day |
| Patient-only Intervention | Caloric Intake (kcal) | 1885 KCALs/day |
p-value: 0.5995% CI: [-132, 233]Mixed Models Analysis
Secondary
Physical Activity
average daily steps over past 7 days from Fitbit, assessed every 6 months with 24 months as primary endpoint
Time frame: 24 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Partner-assisted Intervention | Physical Activity | 7400 steps/day |
| Patient-only Intervention | Physical Activity | 8206 steps/day |
p-value: 0.06995% CI: [-64, 1675]Mixed Models Analysis
Other Pre-specified
Couple Efficacy for Diet
5 items assessed on 11-point scale ranging from 0 (not at all confident) to 10 (very confident)
Time frame: 3 months
Other Pre-specified
Couple Efficacy for Physical Activity
5 items assessed on 11-point scale ranging from 0 (not at all confident) to 10 (very confident)
Time frame: 3 months
Other Pre-specified
Outcome Efficacy for Diet
5 items assessed on 11-point scale ranging from 0 (not at all effective) to 10 (very effective)
Time frame: 3 months
Other Pre-specified
Outcome Efficacy for Physical Activity
5 items assessed on 11-point scale ranging from 0 (not at all effective) to 10 (very effective)
Time frame: 3 months
Other Pre-specified
Social Support for Diet
9 items assessed on 5-point scale (never, rarely, sometimes, often, almost always)
Time frame: 3 months
Other Pre-specified
Social Support for Physical Activity
9 items assessed on 5-point scale (never, rarely, sometimes, often, almost always)
Time frame: 3 months
Other Pre-specified
Transformation of Motivation for Diet
Score based on 12-item Unidimensional Relationship Closeness Scale (1-7, strongly disagree to strongly agree) and single-item Inclusion of Other in Self scale (7 Venn diagrams)
Time frame: 3 months
Other Pre-specified
Transformation of Motivation for Physical Activity
Score based on 12-item Unidimensional Relationship Closeness Scale (1-7, strongly disagree to strongly agree) and single-item Inclusion of Other in Self scale (7 Venn diagrams)
Time frame: 3 months
Other Pre-specified
Use of Communal Coping Strategies for Diet
5 items assessed on 5-point frequency scale (never, sometimes, frequently, often, very often)
Time frame: 3 months
Other Pre-specified
Use of Communal Coping Strategies for Physical Activity
5 items assessed on 5-point frequency scale (never, sometimes, frequently, often, very often)
Time frame: 3 months