NCT03967912

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

November 15, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2020

Completed
Last Updated

December 2, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

May 24, 2019

Last Update Submit

November 19, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    4 months

Secondary Outcomes (5)

  • Change in objectively measured physical function from Baseline to 4 months

    4 months

  • Change in physical function from Baseline to 4 months

    4 months

  • Change in psychosocial measures from Baseline to 4 months

    4 months

  • Changes in physical, mental, and social health

    4 months

  • Changes in caregiver burden

    4 months

Study Arms (1)

MOVE UP for Caregivers

EXPERIMENTAL

12-week lifestyle intervention focusing on diet and activity

Behavioral: MOVE UP

Interventions

MOVE UPBEHAVIORAL

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).

MOVE UP for Caregivers

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Prevention Research Center

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (1)

  • 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.

    PMID: 30480135BACKGROUND

MeSH Terms

Conditions

Body WeightMotor ActivityHealth Behavior

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Steven M Albert, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment Implementation research for adapted effective intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair

Study Record Dates

First Submitted

May 24, 2019

First Posted

May 30, 2019

Study Start

November 15, 2019

Primary Completion

February 15, 2020

Study Completion

February 15, 2020

Last Updated

December 2, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations