NCT03104192

Brief Summary

The goal of this study is to conduct a program of pilot research aimed at developing and evaluating a technology-assisted wellness intervention for older adults with obesity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable obesity

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

April 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 7, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2020

Completed
6 months until next milestone

Results Posted

Study results publicly available

July 1, 2020

Completed
Last Updated

November 29, 2022

Status Verified

November 1, 2022

Enrollment Period

1.3 years

First QC Date

April 3, 2017

Results QC Date

May 6, 2020

Last Update Submit

November 4, 2022

Conditions

Obesity

Keywords

frail elderlytelemedicineobesityrural healthhealth promotionweight loss

Outcome Measures

Primary Outcomes (5)

  • Change in Grip Strength

    Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change.

    Baseline, 12 weeks

  • Change in 5 Times Sit-to-Stand (STS)

    STS measures lower limb strength (minimal change 2.3 s).

    Baseline, 12 weeks

  • Change in Six-Minute Walk Test (6MWT)

    A surrogate for cardiovascular fitness that measures distance (normal 400-700m) related to function. A clinically important difference is 50-55m

    Baseline, 12 weeks

  • Change in Gait Speed (m/s)

    Gait speed is measured by the time it takes to walk 20 meters. Gait speed predicts disability and mortality (significant change 0.1 m/s).

    Baseline, 12 weeks

  • Change in Late-Life Function and Disability Instrument (LLFDI)

    LLFDI consists of a 32-item function and 16-item disability (life-task) scales that correlate with gait speed and lower limb function. Higher points indicate better function. Individual raw scores range from 0 to 80, scaled scores are 0 to 100. Each was assessed at baseline and at 12 weeks. We report the differences between baseline/follow-up. Positive score change reflect improved physical function.

    Baseline, 12 weeks

Secondary Outcomes (19)

  • Change in Behavioral Activation (Patient Activation Measure)

    Baseline, 12 weeks post study

  • Change in Subjective Health Status (PROMIS) Physical

    Baseline, 12-weeks

  • Change in Weight in kg

    Baseline, 12 weeks

  • Change in Waist Circumference in cm

    Baseline, 12 weeks post study

  • Average Steps/Expenditure

    Mean steps over 12 week period of time

  • +14 more secondary outcomes

Other Outcomes (10)

  • Compliance to Whey Protein Consumption as Measured by Percent of the Total Number of Sessions Whey Could Have Been Taken

    Baseline, 12 weeks post study

  • Change in Food Craving Acceptance and Action Questionnaire Score

    Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)

  • Change in Discomfort Intolerance Scale Score

    Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)

  • +7 more other outcomes

Study Arms (4)

Develop & Refine MOWI w/o Amulet (2A)

ACTIVE COMPARATOR

Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults without the use of Amulet technology.

Behavioral: Develop & Refine MOWI w/o Amulet

MOWI Weight Loss Maintenance

EXPERIMENTAL

Evaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI.

Behavioral: MOWI Weight Loss Maintenance

Develop & Refine MOWI w Fitbit (2B)

ACTIVE COMPARATOR

Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.

Behavioral: Develop & Refine MOWI w Fitbit

Develop & Refine MOWI w Fitbit/Protein (2P)

ACTIVE COMPARATOR

Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.

Dietary Supplement: Develop & Refine MOWI w Fitbit/Protein

Interventions

Develop & Refine MOWI w/o AmuletBEHAVIORAL

The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks.

Also known as: MOWI 2A
Develop & Refine MOWI w/o Amulet (2A)
MOWI Weight Loss MaintenanceBEHAVIORAL

Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 minutes in length. The overall structure of the program will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment (acceptance, willingness, thought monitoring, mindful decision making, and values clarification).

Also known as: MOWI LT
MOWI Weight Loss Maintenance
Develop & Refine MOWI w FitbitBEHAVIORAL

The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.

Also known as: MOWI 2B-2
Develop & Refine MOWI w Fitbit (2B)
Develop & Refine MOWI w Fitbit/ProteinDIETARY_SUPPLEMENT

The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.

Also known as: MOWI Protein-2
Develop & Refine MOWI w Fitbit/Protein (2P)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • All Aims:
  • Age ≥65 years
  • Body Mass Index (BMI) ≥ 30kg/m\^2
  • Waist circumference ≥88cm in females or ≥102cm in males
  • Aims 2 \& 3:
  • Have Wi-Fi high speed internet
  • Able to obtain medical clearance from doctor
  • Have less than a 5% weight loss in past 6 months
  • No advanced co-morbidity
  • No exercise restrictions
  • Not involved in other research studies that may interfere with participation

You may not qualify if:

  • Severe mental or life-threatening illness
  • Dementia
  • Substance use
  • History of bariatric surgery
  • Suicidal ideation
  • Unable to perform measures
  • Reside in nursing home
  • No advanced co-morbidity
  • No exercise restrictions
  • Not involved in other research studies that may interfere with participation
  • Aim 4 - had to have completed Aims 2 or 3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Related Publications (1)

  • Petersen CL, Christensen BC, Batsis JA. Weight management intervention identifies association of decreased DNA methylation age with improved functional age measures in older adults with obesity. Clin Epigenetics. 2021 Mar 2;13(1):46. doi: 10.1186/s13148-021-01031-7.

    PMID: 33653394DERIVED

Related Links

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

Proteins

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Results Point of Contact

Title
John A. Batsis, MD
Organization
Dartmouth-Hitchcock
john.batsis@gmail.com
603-650-5000

Study Officials

  • John A Batsis, MD

    Dartmouth-Hitchcock Medical Center / Dartmouth Medical School

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Two Arm Pilot Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 3, 2017

First Posted

April 7, 2017

Study Start

September 1, 2017

Primary Completion

January 3, 2019

Study Completion

January 11, 2020

Last Updated

November 29, 2022

Results First Posted

July 1, 2020

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)