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MOVE UP Lifestyle Intervention for Caregivers

Primary Purpose

Body Weight, Healthy Diet, Physical Activity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MOVE UP

About this trial

This is an interventional prevention trial for Body Weight

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Past MOVE UP participant.
If weight loss in the past year is >=10% body weight.
Use of wheelchair; participant must be willing and able to increase physical activity.
Uncontrolled diabetes mellitus (FBS > 30 & A1C > 11%); to be assessed by physician on medical release.
Uncontrolled hypertension (SBP > 180/110) %); to be assessed by physician on medical release.
Recent overnight hospitalization (past 6 months).
Active treatment for cancer (including melanoma).
Significant visual or hearing impairment.
Significant cognitive disorder/relevant and significant psychiatric disorder (to be assessed on medical release).
Inability to communicate in English/lack of translator.
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.
Currently enrolled in a weight loss program, such as Weight Watchers.
Inability or unwillingness to attend the majority of sessions.
In the past year, participating in (other) ways of losing weight, such as bariatric surgery, prescription medications, or non-surgical interventions (reviewed by investigators).
Unable to obtain medical clearance by session 2.
Not acting as a caregiver.

Sites / Locations

University of Pittsburgh Prevention Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MOVE UP for Caregivers

Arm Description

12-week lifestyle intervention focusing on diet and activity

Outcomes

Primary Outcome Measures

Body weight change from Baseline to 4 months

Number of participants with at least a 5% decrease in body weight from baseline at 4 months

Secondary Outcome Measures

Change in objectively measured physical function from Baseline to 4 months

Observed performance measure using SPPB. Scores range from 0 (worst performance) to 12 (best performance)

Change in physical function from Baseline to 4 months

Self-reports using CHAMPS. Score range is 0- 793, with higher scores indicating greater physical activity.

Change in psychosocial measures from Baseline to 4 months

Self-report using CES-D. Score range 0-60, in which higher scores suggest a greater presence of depressive symptoms.

Changes in physical, mental, and social health

Self-report using PROMIS ® (Patient-Reported Outcomes Measurement Information System), which is a set of person-centered measures that evaluates physical, mental, and social health. The PROMIS-29 consists of self-report items from seven domains (Depression, Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities). Summed scores from each domain can be converted into a T-score using a table provided by test developers. The table rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A score of 50 is the average for the United States general population, and a person with a T-score of 40 is one SD below the mean. For this exploratory measure we are interested to establish effect sizes for MOVE UP, that is, how much of a change in T score is on average associated with the MOVE UP lifestyle intervention.

Changes in caregiver burden

Self-report using Short Form Zarit Burden Interview (ZBI-12). Score range 0-48, in which higher scores indicate a greater burden.

Full Information

NCT ID

NCT03967912

First Posted

May 24, 2019

Last Updated

November 19, 2021

Sponsor

University of Pittsburgh

Collaborators

Centers for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT03967912

Brief Title

MOVE UP Lifestyle Intervention for Caregivers

Official Title

Mobility and Vitality Lifestyle Program-Caregivers

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

November 15, 2019 (Actual)

Primary Completion Date

February 15, 2020 (Actual)

Study Completion Date

February 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

Collaborators

Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Body Weight, Healthy Diet, Physical Activity, Health Behavior, Healthy Aging

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single Group Assignment Implementation research for adapted effective intervention

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MOVE UP for Caregivers

Arm Type

Experimental

Arm Description

12-week lifestyle intervention focusing on diet and activity

Intervention Type

Behavioral

Intervention Name(s)

MOVE UP

Intervention Description

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).

Primary Outcome Measure Information:

Title

Body weight change from Baseline to 4 months

Description

Number of participants with at least a 5% decrease in body weight from baseline at 4 months

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Change in objectively measured physical function from Baseline to 4 months

Description

Observed performance measure using SPPB. Scores range from 0 (worst performance) to 12 (best performance)

Time Frame

4 months

Title

Change in physical function from Baseline to 4 months

Description

Self-reports using CHAMPS. Score range is 0- 793, with higher scores indicating greater physical activity.

Time Frame

4 months

Title

Change in psychosocial measures from Baseline to 4 months

Description

Self-report using CES-D. Score range 0-60, in which higher scores suggest a greater presence of depressive symptoms.

Time Frame

4 months

Title

Changes in physical, mental, and social health

Description

Time Frame

4 months

Title

Changes in caregiver burden

Description

Self-report using Short Form Zarit Burden Interview (ZBI-12). Score range 0-48, in which higher scores indicate a greater burden.

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 50-75 years of age BMI >=27.0, but <45.0 Able to consent for participation and data collection. Medical clearance from physician/health care provider before session 2 in program. Ability to walk with or without assistive device. Acting as a caregiver to someone with dementia, a serious illness, and/or a developmental or physical disability. Exclusion Criteria: Past MOVE UP participant. If weight loss in the past year is >=10% body weight. Use of wheelchair; participant must be willing and able to increase physical activity. Uncontrolled diabetes mellitus (FBS > 30 & A1C > 11%); to be assessed by physician on medical release. Uncontrolled hypertension (SBP > 180/110) %); to be assessed by physician on medical release. Recent overnight hospitalization (past 6 months). Active treatment for cancer (including melanoma). Significant visual or hearing impairment. Significant cognitive disorder/relevant and significant psychiatric disorder (to be assessed on medical release). Inability to communicate in English/lack of translator. 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. Currently enrolled in a weight loss program, such as Weight Watchers. Inability or unwillingness to attend the majority of sessions. In the past year, participating in (other) ways of losing weight, such as bariatric surgery, prescription medications, or non-surgical interventions (reviewed by investigators). Unable to obtain medical clearance by session 2. Not acting as a caregiver.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven M Albert, PhD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pittsburgh Prevention Research Center

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15261

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30480135

Citation

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.

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