Lower Extremity AmputationMOVE-LEAPNCT02085785
Weight Loss Intervention for Individuals With Lower Extremity Amputation
A study testing Coached group and Screened only in people with Lower Extremity Amputation, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this study is to pilot test a program to help overweight and obese individuals with a lower extremity amputation (LEA) lose weight and become more physically active. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Lower Extremity Amputation
- What is being tested?
- Coached group and Screened only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2014to 1 May 2018
- 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 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lower extremity amputation (including toes) for at least 1 year
- overweight or obese
- <60 minutes drive-time to VA Puget Sound Health Care System - Seattle campus, willing to be randomized
- provides written, informed consent
- able to perform some form of aerobic exercise (e.g., walking, bicycling, swimming)
- has telephone
- able to complete study assessments
Who cannot join
- Co-morbidities which may be contraindicated or indicate no potential benefit from weight loss or increasing physical activity
- unlikely to be able to adhere to study protocol and complete questionnaires and measurements reliably
- recent or current (last 6 months) participation in a weight loss program, including taking weight loss medications
- only uses motorized (non-manual) wheelchair
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
About this study
Official title: Home-based Weight Loss Intervention for Individuals With Lower Extremity Amputation
The purpose of this study is to pilot test a program to help overweight and obese individuals with a lower extremity amputation (LEA) lose weight and become more physically active. The investigators will randomize approximately 30 individuals to either a self-directed weight loss program (n=15) or a coached weight loss program (n=15). The primary purpose of this pilot study is to determine if a home-based weight loss/physical activity (PA) intervention is feasible in individuals with a LEA. MOVE-LEAP is a 20-week program that involves 11 phone calls from a health coach and a single home visit by a physical therapist.
This pilot study aims to:
- test the feasibility of recruiting overweight/obese individuals with LEA into a randomized trial;
- assess whether the intervention can be delivered with high fidelity, and
- evaluate whether the intervention is acceptable to and safe as determined by participant feedback, participation and retention for outcome measures.
Read the detailed description
Participants randomized to the intervention arm will receive (1) a home visit by an exercise specialist and (2) a 20-week telephone-delivered weight loss program, modeled on the VA's Telephone Lifestyle Coaching Program (MOVE!TLC). All participants (both the coached arm and self-directed arm) will be mailed a MOVE-LEAP packet [containing eating and physical activity logs, information on how to set weight loss goals, suggestions for physical activity/exercise, dietary guides, etc.), a MOVE-LEAP handout booklet, calories counting book, a pedometer, exercise digital versatile disc (DVD), and a flip-booklet with exercises ("Exercise Guide for Persons with Limb Loss"). A bathroom scale will be provided for participants who do not already own one.
Participants in the coached arm will receive a home visit by an exercise specialist. This visit will occur 1-3 weeks after randomization. The exercise specialist will assess the participant's capabilities and interest regarding physical activity as well as his/her home environment for physical activity. Since each participant may have different physical capabilities and limitations, the type and intensity of physical activity will be tailored to each participant's preferences and their home and neighborhood/community environment and resources. If the participant is interested in performing physical activity outside their home, study staff will provide them with information about community resources for physical activities.
Participants in the coached arm will receive 11 calls by a study health coach. During the phone calls (weekly initially and then every other week), the health coach will review progress and help the participant to set "SMART" goals (Specific, Measurable, Attainable, Relevant and Time-limited) and will use motivational interviewing techniques to help the participant achieve those goals. Motivational interviewing is a style of counseling meant to increase participant engagement through strategic use of open-ended questions, reflective listening and positive affirmations. The study staff will review the participant's progress on his or her goals and help him or her problem solve to resolve challenges and modify goals as needed. During each session, the coach will discuss an educational topic relating to weight loss. Written materials on each topic are included the booklet.
- Conditions
- Lower Extremity Amputation
- Being tested
- Coached group, Self-directed control group, Screened only
- Keywords
- weight loss, exercise, home-based, lower extremity amputation, pilot study
- Medical subject headings
- Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coached groupBehavioural
Participants randomized to the coached arm will receive 1) education and self-monitoring materials [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur
Self-directed control groupBehavioural
Participants randomized to the self-directed control arm will receive the same educational and self-monitoring materials as the coached group [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.
Screened onlyOther
Screened only - No intervention -- individuals who are contacted and/or screened for eligibility
| Study group | Role | What they receive |
|---|---|---|
| Coached | Experimental | Participants randomized to the coached arm will receive the same educational and self-monitoring materials as the self-directed group. In addition, participants in the coached arm will receive 11 calls from a health coach and a single visit to their home by an exercise specialist. Receives: Behavioral: Coached group |
| Self-directed | Active comparator | Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group, but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own. Receives: Behavioral: Self-directed control group |
| Screened | Other | Individuals who were contacted to inform them about the study or who contacted study personnel to express an interest in participating. This group is presented in order to present statistics on feasibility regarding recruitment Receives: Other: Screened only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Individuals That Were Randomized of Those Contacted (Feasibility)
Specific components include yield by method, recruitment rate, refusal rates and reasons
Measured: During recruitment (expected duration of 12-15 months)
Secondary outcomes (4)
Feasibility - Retention
Number of randomized individuals who complete baseline and study exit visit
Measured: Follow-up assessments (all participants) and during intervention (intervention group only) (weekly, for 20 weeks)
Acceptability
Acceptability of intervention will be assessed via a brief satisfaction survey - % who would recommend the program to a friend
Measured: At follow-up assessment (20-weeks follow-up)
Change in Weight
Changes between baseline and 20-weeks later (end of intervention)
Measured: Baseline and follow-up assessment (20-weeks after randomization)
Change in 6-minute Walk Distance
Change in 6-minute walk distance (ft) from baseline to follow-up
Measured: Baseline and at follow-up assessment (20-weeks after randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study start20 Feb 2014
- Primary completion16 Nov 2015
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Extremity AmputationStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alyson J. Littman, PhD MPH, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085785
- Sponsor's protocol ID
- F6982-Wa
- Acronym
- MOVE-LEAP
- Status last verified
- May 2018
- First submitted
- 17 Jan 2014
- Last updated
- 29 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Littman AJ, Haselkorn JK, Arterburn DE, Boyko EJ. Pilot randomized trial of a telephone-delivered physical activity and weight management intervention for individuals with lower extremity amputation. Disabil Health J. 2019 Jan;12(1):43-50. doi: 10.1016/j.dhjo.2018.08.002. Epub 2018 Aug 10.
PubMed 30115584
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Weight Loss Intervention for Individuals With Lower Extremity Amputation
- ClinicalTrials.gov ID
- NCT02085785
- Acronym / sponsor ID
- MOVE-LEAP / F6982-Wa
- Conditions
- Lower Extremity Amputation
- Keywords
- weight loss, exercise, home-based, lower extremity amputation, pilot study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 20 Feb 2014 (actual)
- Primary completion
- 16 Nov 2015 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Posted 3 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to pilot test a program to help overweight and obese individuals with a lower extremity amputation (LEA) lose weight and become more physically active. The investigators will randomize approximately 30 individuals to either a self-directed weight loss program (n=15) or a coached weight loss program (n=15). The primary purpose of this pilot study is to determine if a home-based weight loss/physical activity (PA) intervention is feasible in individuals with a LEA. MOVE-LEAP is a 20-week program that involves 11 phone calls from a health coach and a single home visit by a physical therapist.
This pilot study aims to:
- test the feasibility of recruiting overweight/obese individuals with LEA into a randomized trial;
- assess whether the intervention can be delivered with high fidelity, and
- evaluate whether the intervention is acceptable to and safe as determined by participant feedback, participation and retention for outcome measures.
Detailed description
Participants randomized to the intervention arm will receive (1) a home visit by an exercise specialist and (2) a 20-week telephone-delivered weight loss program, modeled on the VA's Telephone Lifestyle Coaching Program (MOVE!TLC). All participants (both the coached arm and self-directed arm) will be mailed a MOVE-LEAP packet [containing eating and physical activity logs, information on how to set weight loss goals, suggestions for physical activity/exercise, dietary guides, etc.), a MOVE-LEAP handout booklet, calories counting book, a pedometer, exercise digital versatile disc (DVD), and a flip-booklet with exercises ("Exercise Guide for Persons with Limb Loss"). A bathroom scale will be provided for participants who do not already own one.
Participants in the coached arm will receive a home visit by an exercise specialist. This visit will occur 1-3 weeks after randomization. The exercise specialist will assess the participant's capabilities and interest regarding physical activity as well as his/her home environment for physical activity. Since each participant may have different physical capabilities and limitations, the type and intensity of physical activity will be tailored to each participant's preferences and their home and neighborhood/community environment and resources. If the participant is interested in performing physical activity outside their home, study staff will provide them with information about community resources for physical activities.
Participants in the coached arm will receive 11 calls by a study health coach. During the phone calls (weekly initially and then every other week), the health coach will review progress and help the participant to set "SMART" goals (Specific, Measurable, Attainable, Relevant and Time-limited) and will use motivational interviewing techniques to help the participant achieve those goals. Motivational interviewing is a style of counseling meant to increase participant engagement through strategic use of open-ended questions, reflective listening and positive affirmations. The study staff will review the participant's progress on his or her goals and help him or her problem solve to resolve challenges and modify goals as needed. During each session, the coach will discuss an educational topic relating to weight loss. Written materials on each topic are included the booklet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Coached | Experimental | Behavioral: Coached groupParticipants randomized to the coached arm will receive the same educational and self-monitoring materials as the self-directed group. In addition, participants in the coached arm will receive 11 calls from a health coach and a single visit to their home by an exercise specialist. |
| Self-directed | Active comparator | Behavioral: Self-directed control groupParticipants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group, but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own. |
| Screened | Other | Other: Screened onlyIndividuals who were contacted to inform them about the study or who contacted study personnel to express an interest in participating. This group is presented in order to present statistics on feasibility regarding recruitment |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Lower extremity amputation (including toes) for at least 1 year
- overweight or obese
- <60 minutes drive-time to VA Puget Sound Health Care System - Seattle campus, willing to be randomized
- provides written, informed consent
- able to perform some form of aerobic exercise (e.g., walking, bicycling, swimming)
Key exclusion criteria (4 listed)
- Co-morbidities which may be contraindicated or indicate no potential benefit from weight loss or increasing physical activity
- unlikely to be able to adhere to study protocol and complete questionnaires and measurements reliably
- recent or current (last 6 months) participation in a weight loss program, including taking weight loss medications
- only uses motorized (non-manual) wheelchair
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coached groupParticipants randomized to the coached arm will receive 1) education and self-monitoring materials [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur | Behavioural | Coached |
| Self-directed control groupParticipants randomized to the self-directed control arm will receive the same educational and self-monitoring materials as the coached group [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own. | Behavioural | Self-directed |
| Screened onlyScreened only - No intervention -- individuals who are contacted and/or screened for eligibility | Other | Screened |
Primary outcome
Number of Individuals That Were Randomized of Those Contacted (Feasibility)
Time frame: During recruitment (expected duration of 12-15 months)
Specific components include yield by method, recruitment rate, refusal rates and reasons
4 secondary outcomes
Feasibility - Retention
Time frame: Follow-up assessments (all participants) and during intervention (intervention group only) (weekly, for 20 weeks)
Acceptability
Time frame: At follow-up assessment (20-weeks follow-up)
Change in Weight
Time frame: Baseline and follow-up assessment (20-weeks after randomization)
Change in 6-minute Walk Distance
Time frame: Baseline and at follow-up assessment (20-weeks after randomization)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30115584Littman AJ, Haselkorn JK, Arterburn DE, Boyko EJ. Pilot randomized trial of a telephone-delivered physical activity and weight management intervention for individuals with lower extremity amputation. Disabil Health J. 2019 Jan;12(1):43-50. doi: 10.1016/j.dhjo.2018.08.002. Epub 2018 Aug 10.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alyson J. Littman, PhD MPH principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coached group and Screened only in people with Lower Extremity Amputation, run by VA Office of Research and Development 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 7 inclusion and 4 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 Jun 2018. 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 3 Mar 2017). 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?
Number of Individuals That Were Randomized of Those Contacted (Feasibility) (time frame: During recruitment (expected duration of 12-15 months)). 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 NCT02085785, 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 Jun 2018.