MOVE UP Lifestyle Intervention for Caregivers

NCT ID: NCT03967912

Last Updated: 2021-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-15

Study Completion Date

2020-02-15

Brief Summary

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In prior research the Mobility and Vitality Lifestyle Program for healthy aging and weight management (MOVE UP) was effective in producing a mean loss of \>= 5% body weight, with increased physical activity and reduced fatigue. This research will pilot a modified and streamlined version to see if it will be similarly effective for caregivers of family members or friends who have dementia, physical and/or developmental issues, or health problems.

Detailed Description

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The investigators aim to test the feasibility of delivery of a modified and streamlined lifestyle program in volunteer community settings and to provide pilot data to inform the design of future randomized controlled trials that may improve physical and mental health in older adults (50-75) who are providing care for a family member or friend who has dementia, physical and/or developmental issues, or health problems. Current objectives include:

1 . Adapt and pilot the previously studied 32-session, 13-month MOVE UP intervention to a streamlined 12-session (4-month) community-based translational behavioral weight management program. The pilot program will be delivered by a staff interventionist.

2\. Implement and evaluate the program's impact on weight and healthy lifestyle changes, including physical performance outcomes, at 2 sites, each with at least 6 eligible obese and caregiving adults ages 50-75 years old.

Conditions

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Body Weight Healthy Diet Physical Activity Health Behavior Healthy Aging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Group Assignment Implementation research for adapted effective intervention
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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MOVE UP for Caregivers

12-week lifestyle intervention focusing on diet and activity

Group Type EXPERIMENTAL

MOVE UP

Intervention Type BEHAVIORAL

Each of the 12 group sessions will focus on incremental behavioral strategies for maintaining healthy eating, activity, and weight loss.behaviors. Body weight will be measured in-person session and participants will also to measure their body weight on their in Session 3, participants are given physical activity goal of 10 minutes/day, 50 minutes/week. The goal is raised by 5 minutes/day, 25 minutes/week every other session, the final goal being 30 minutes/day, 150 minutes/week. All subjects will be recommended to engage in an energy restricted dietary intervention that evidence demonstrates has effectively reduced body weight by 5-7% within the initial 4 months of the intervention. This will include reducing energy intake to 1200 to 1800 kcal/d based on initial body weight (\<200 pounds = 1200 kcal/d; 200 to 250 pounds = 1500 kcal/d; \>250 pounds = 1800 kcal/d).

Interventions

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MOVE UP

Each of the 12 group sessions will focus on incremental behavioral strategies for maintaining healthy eating, activity, and weight loss.behaviors. Body weight will be measured in-person session and participants will also to measure their body weight on their in Session 3, participants are given physical activity goal of 10 minutes/day, 50 minutes/week. The goal is raised by 5 minutes/day, 25 minutes/week every other session, the final goal being 30 minutes/day, 150 minutes/week. All subjects will be recommended to engage in an energy restricted dietary intervention that evidence demonstrates has effectively reduced body weight by 5-7% within the initial 4 months of the intervention. This will include reducing energy intake to 1200 to 1800 kcal/d based on initial body weight (\<200 pounds = 1200 kcal/d; 200 to 250 pounds = 1500 kcal/d; \>250 pounds = 1800 kcal/d).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. 50-75 years of age
2. BMI \>=27.0, but \<45.0
3. Able to consent for participation and data collection.
4. Medical clearance from physician/health care provider before session 2 in program.
5. Ability to walk with or without assistive device.
6. Acting as a caregiver to someone with dementia, a serious illness, and/or a developmental or physical disability.

Exclusion Criteria

1. Past MOVE UP participant.
2. If weight loss in the past year is \>=10% body weight.
3. Use of wheelchair; participant must be willing and able to increase physical activity.
4. Uncontrolled diabetes mellitus (FBS \> 30 \& A1C \> 11%); to be assessed by physician on medical release.
5. Uncontrolled hypertension (SBP \> 180/110) %); to be assessed by physician on medical release.
6. Recent overnight hospitalization (past 6 months).
7. Active treatment for cancer (including melanoma).
8. Significant visual or hearing impairment.
9. Significant cognitive disorder/relevant and significant psychiatric disorder (to be assessed on medical release).
10. Inability to communicate in English/lack of translator.
11. Currently enrolled in another research study that could impact study outcomes or interfere with either study. Exclude if less than 12 months post-graduation from previously enrolled study.
12. Currently enrolled in a weight loss program, such as Weight Watchers.
13. Inability or unwillingness to attend the majority of sessions.
14. In the past year, participating in (other) ways of losing weight, such as bariatric surgery, prescription medications, or non-surgical interventions (reviewed by investigators).
15. Unable to obtain medical clearance by session 2.
16. Not acting as a caregiver.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Steven M. Albert

Professor and Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven M Albert, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh Prevention Research Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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Venditti EM, Zgibor JC, Vander Bilt J, Kieffer LA, Boudreau RM, Burke LE, Glynn NW, Jakicic JM, Smith KJ, Semler LN, Rager JR, Albert SM, Newman AB. Mobility and Vitality Lifestyle Program (MOVE UP): A Community Health Worker Intervention for Older Adults With Obesity to Improve Weight, Health, and Physical Function. Innov Aging. 2018 Jun 18;2(2):igy012. doi: 10.1093/geroni/igy012. eCollection 2018 Jun.

Reference Type BACKGROUND
PMID: 30480135 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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U48DP005001

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY18110005

Identifier Type: -

Identifier Source: org_study_id