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ObesityNCT03104192

MOWI Research Pilot

A study testing Develop & Refine MOWI w/o Amulet, MOWI Weight Loss Maintenance and Develop & Refine MOWI w Fitbit in people with Obesity, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Develop & Refine MOWI w/o Amulet, MOWI Weight Loss Maintenance and Develop & Refine MOWI w Fitbit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
1 siteUnited States
Study dates
1 Sep 2017to 11 Jan 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • Severe mental or life-threatening illness
  • Dementia
  • Substance use
  • History of bariatric surgery
  • Suicidal ideation
  • Unable to perform measures
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

Other trials in United States

About this study

Official title: Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Research Pilot

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.

Read the detailed description

The national epidemic of obesity is also affecting older adults, and is associated with an increased risk of disability, nursing home placement and early mortality. Conventional weight loss programs have the potential to reduce body fat, but are difficult to access for older obese adults due to transportation and mobility challenges. The overarching 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.

Study Timeline:

September 2017 to June 2018:

Goal: Conduct a pilot study of improving weight and physical function in older adults with obesity. An mHealth Obesity Wellness Intervention (MOWI) will integrate Amulet +/- Fitbi with a weekly individual dietician-led nutritional session, along with twice weekly physical therapist led group exercise session.

Participation Duration: Three times weekly for 3 months

Conditions
Obesity
Being tested
Develop & Refine MOWI w/o Amulet, MOWI Weight Loss Maintenance, Develop & Refine MOWI w Fitbit, Develop & Refine MOWI w Fitbit/Protein
Keywords
frail elderly, telemedicine, obesity, rural health, health promotion, weight loss
Medical subject headings
Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Develop & Refine MOWI w/o AmuletBehavioural

    Also called MOWI 2A

    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.

  • MOWI Weight Loss MaintenanceBehavioural

    Also called MOWI LT

    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).

  • Develop & Refine MOWI w FitbitBehavioural

    Also called MOWI 2B-2

    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.

  • Develop & Refine MOWI w Fitbit/ProteinDietary supplement

    Also called MOWI Protein-2

    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.

Study groups in NCT03104192
Study groupRoleWhat they receive
Develop & Refine MOWI w/o Amulet (2A)Active comparatorDevelop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults without the use of Amulet technology.
Receives: Behavioral: Develop & Refine MOWI w/o Amulet
MOWI Weight Loss MaintenanceExperimentalEvaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI.
Receives: Behavioral: MOWI Weight Loss Maintenance
Develop & Refine MOWI w Fitbit (2B)Active comparatorDevelop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.
Receives: Behavioral: Develop & Refine MOWI w Fitbit
Develop & Refine MOWI w Fitbit/Protein (2P)Active comparatorDevelop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.
Receives: Dietary Supplement: Develop & Refine MOWI w Fitbit/Protein

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Grip Strength

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

    Measured: Baseline, 12 weeks

  2. Change in 5 Times Sit-to-Stand (STS)

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

    Measured: Baseline, 12 weeks

  3. 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

    Measured: Baseline, 12 weeks

  4. 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).

    Measured: Baseline, 12 weeks

  5. 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.

    Measured: Baseline, 12 weeks

Secondary outcomes (19)

  1. Change in Behavioral Activation (Patient Activation Measure)

    Patient Activation Measure (PAM) assesses knowledge, confidence and skill for managing health and grouped into 4 levels revealing insights into attitudes, motivators, behaviors \& outcomes. Higher points indicate better activation. Measures are scored 0-100 units. Scores below reflect changes between baseline and follow-up at 12-weeks. A positive change score indicates improvement in activation

    Measured: Baseline, 12 weeks post study

  2. Change in Subjective Health Status (PROMIS) Physical

    Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Short Form. PROMIS is a 10-item instrument capturing physical, mental and social aspects of quality of life having undergone quantitative appraisal and is non-proprietary. Higher points indicate better health. Raw scores are scaled to 0-100. 50 is the mean, 10 points indicates 1 standard deviation. Positive change scores listed below indicate an improvement in subjective health

    Measured: Baseline, 12-weeks

  3. Change in Weight in kg

    Change in weight in kg

    Measured: Baseline, 12 weeks

  4. Change in Waist Circumference in cm

    Change in waist and hip circumference in cm

    Measured: Baseline, 12 weeks post study

  5. Average Steps/Expenditure

    Average Steps will be measured over a 12 week period

    Measured: Mean steps over 12 week period of time

  6. Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of Activities

    CHAMPS is a self-reported tool in older adults that assesses activity levels and types -

    Measured: Change Score between baseline and 12 weeks

  7. Change in Body Composition - Lean Mass

    Lean mass was assessed using bioelectrical impedance for 2P and 2B. This technique was not available for MOWI 2A participants and hence not measured

    Measured: Baseline, 12 weeks

  8. Change in Energy Expenditure

    Resting metabolic rate, Change Score (kCal) from Baseline to 12 weeks

    Measured: Baseline to 12 weeks

  9. Change in Fasting Plasma Glucose

    Fasting Plasma Glucose

    Measured: Baseline, 12 weeks

  10. Change in Participant Satisfaction Questionnaire Score

    The Participant Satisfaction Questionnaire is a 12-item questionnaire which measures participant satisfaction with intervention participation using a Likert scale (0-5 point scale: very unsatisfied = 0 to very satisfied = 4). Total scores range 0-60: higher scores indicate greater satisfaction with the intervention.Three additional sub-items ask participants to rate their preference for the frequency of sessions, length of group meetings, and total number of group meetings using a Likert scale (-1 - 1 point scale: too few/too short = -1 to 1 = too much/too long). Each of these three items will be interpreted individually and not included in a summed total score. Additionally, this questionnaire includes 1 open-ended response item where participants are asked to leave any additional comments they may have regarding their level of satisfaction with the intervention.

    Measured: 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))

  11. Change in Credibility and Expectancy Questionnaire Score

    The Credibility and Expectancy Questionnaire is a 6-item questionnaire which measures expectancies regarding intervention participation and intervention rationale credibility using a Likert scale (0-10 point scale: responses are anchored to question stems such that, not at all logical/not at all effective/not at all confident/no credibility/not at all comfortable = 0 and very logical/very effective/very confident/high credibility = 10). Total scores range 0-50: higher scores indicate more favorable expectancies regarding participation in the intervention/greater perceived intervention credibility. Additionally, this questionnaire includes 1 open-ended response item that asks participants to leave any additional comments they may have regarding their expectations for the intervention

    Measured: Baseline (of maintenance intervention) and 6 months (into maintenance) - pre/post

  12. Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of Not Exercising Activities

    CHAMPS is a self-reported tool in older adults that assesses activity levels and types -

    Measured: Change Score between baseline and 12 weeks

  13. Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Duration

    CHAMPS is a self-reported tool in older adults that assesses activity levels and types -

    Measured: Change Score between baseline and 12 weeks

  14. Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS)

    CHAMPS is a self-reported tool in older adults that assesses activity levels and types -

    Measured: Change in KCal between baseline and 12 weeks

  15. Change in Insulin Level

    insulin

    Measured: Baseline, 12 weeks

  16. Change in C-peptide

    C-peptide

    Measured: Baseline, 12 weeks

  17. Change in C-reactive Protein

    C-reactive protein

    Measured: Baseline, 12 weeks

  18. Change in Tumor Necrosis Factor Alpha

    tumor necrosis factor alpha

    Measured: Baseline, 12 weeks

  19. Change in Interleukin 6

    Interleukin 6

    Measured: Baseline, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2017
  2. Study start1 Sep 2017
  3. Primary completion3 Jan 2019
  4. Study completion11 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Single group
Model description
Two Arm Pilot Study
Masking
None (open label)
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03104192
Sponsor's protocol ID
D16182_2
Other IDs
K23AG051681
Status last verified
Nov 2022
First submitted
3 Apr 2017
Last updated
29 Nov 2022
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33653394

Questions about this trial

What is this clinical trial studying?

A study testing Develop & Refine MOWI w/o Amulet, MOWI Weight Loss Maintenance and Develop & Refine MOWI w Fitbit in people with Obesity, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Grip Strength (time frame: Baseline, 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03104192, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.

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MOWI Research Pilot (NCT03104192) | AzTrials