NCT05646771已完成不适用
Feasibility Study for Collaborate2Lose: Collaborating With Support Persons to Improve Long-term Weight Loss
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Retention Rate for primary outcome
研究概览
简要总结
In this feasibility study, dyads comprising a Veteran with obesity and a cohabiting adult support person will participate in group-based weight management counseling. Counseling will be delivered using an approved virtual technology platform. The curriculum is based on the VA national MOVE! weight management curriculum and involves additional content focusing on couples' communication skills.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years or older
- •BMI ≥ 30 kg/m2
- •Had at least one visit with their primary care provider at the Madison VA within the past year (in-person or telehealth)
- •Weight ≤ 420lbs due to limit of the study scales
- •Cohabitating and daily contact for at least the past 6 months with an adult who can provide support (e.g. spouse/domestic partner, sibling, friend, family member) during the study period
- •Desire to lose weight
- •Ability to speak English
- •Agrees to attend visits per protocol
- •Score of at least 4 out of 6 on a validated cognitive screener
- •Access to hardware and internet connection to enable participation with approved virtual platform
- •Individual email address
- •Able to stand on a scale without assistance
排除标准
- •Medication other than metformin, incretin mimetics and incretin enhancers for type 2 diabetes due to increased risk for hypoglycemia
- •Active dementia, psychiatric illness, or substance abuse
- •History of bariatric surgery
- •Diuretic medication doses higher than hydrochlorothiazide 25 mg daily, furosemide 40 mg daily, Torsemide 20 mg daily, Bumetanide 1 mg daily or any use of Metolazone). Use of potassium-sparing diuretics is acceptable.
- •Chronic kidney disease at stage 4 or higher
- •Participation in MOVE! in the past 3 months
- •Currently enrolled in a research or clinical program focusing on lifestyle change
- •Pregnancy or planning to become pregnant in the next 18 months, or breastfeeding
- •Psychiatric illness not well-controlled by medication or therapy
- •Score ≥ 8 on alcohol abuse screener
- •Use of any drugs not prescribed, excluding cannabis
- •Weight loss ≥ 10lb in the month prior to screening
- •Living in a facility such as a nursing home, skilled nursing facility, or assisted living facility
- •Is unable to control what food is prepared and/or served in household
- •Problems with hearing that prevent attendance to a virtual class and talking on the telephone
- •Currently enrolled in a research or clinical program focusing on lifestyle change
- •History of bariatric surgery (reconfirm) or planning to have bariatric surgery in the next 18 months
- •Current use of weight loss medications
- •Worsening heart failure requiring medication dose change in the past 6 months
- •Hospitalization for heart problems in the past 6 months
- •Current treatment or treatment in the past 6 months for cancer (besides non-melanoma skin cancers)
- •Dizziness or lightheadedness at rest or associated with physical activity
- •Chest pain in the past 6 months
- •Inclusion Criteria (support person):
- •Aged 18 years or older
- •Willing to participate
- •Score of at least 4 out of 6 on a validated cognitive screener
- •Ability to speak English
- •Exclusion Criteria (support person):
- •Underweight (BMI < 18.5 kg/m2)
- •Active dementia, uncontrolled psychiatric illness, or substance abuse
- •Living in a facility such as a nursing home, skilled nursing facility, or assisted living facility
- •Problems with hearing that prevent attendance to a virtual class and talking on the telephone
- •Any severe health issue that would impair the partner's ability to provide support
研究组 & 干预措施
Partner-Supported
Experimental
Dyads comprised of one Veteran and a cohabitating support person will participate in a behavioral weight management intervention.
干预措施: Partner support (Behavioral)
结局指标
主要结局
Retention Rate for primary outcome
时间窗: 16 weeks
The outcome assessment retention rate at 16 weeks will be calculated as \[#of index participants who provide a weight at 16 weeks/number who provided a baseline weight\]. Our metric is at least 80% retention at 16 weeks.
Screening to enrollment ratio
时间窗: baseline
We will calculate the screening to enrollment ratio. Our feasibility metric is 2:1 (i.e., 2 people start the phone screening in order to have one provide consent).
次要结局
- Weight(16 weeks)
- Intervention adherence(14 weeks)
研究者
研究点 (1)
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