NCT02085785: MOVE-LEAP

Weight Loss Intervention for Individuals With Lower Extremity Amputation

Completed NA Results posted Last updated 29 June 2018

What this trial tests

NA trial testing Coached group in Lower Extremity Amputation in 15 participants. Completed in 1 May 2018.

Timeline

20 February 2014

Primary endpoint
16 November 2015

1 May 2018

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	15
Start date	20 February 2014
Primary completion	16 November 2015
Estimated completion	1 May 2018
Sites	1 location across United States

Drugs / interventions tested

• Coached group
• Self-directed control group
• Screened only

Conditions studied

• Lower Extremity Amputation — all drugs for Lower Extremity Amputation →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 69, any sex, with Lower Extremity Amputation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Individuals That Were Randomized of Those Contacted (Feasibility) Primary · During recruitment (expected duration of 12-15 months)

Specific components include yield by method, recruitment rate, refusal rates and reasons

Group	Value	95% CI
Overall Study Feasibility	15

Feasibility - Retention Secondary · Follow-up assessments (all participants) and during intervention (intervention group only) (weekly, for 20 weeks)

Number of randomized individuals who complete baseline and study exit visit

Group	Value	95% CI
Coached	5
Self-directed	6

Acceptability Secondary · At follow-up assessment (20-weeks follow-up)

Acceptability of intervention will be assessed via a brief satisfaction survey - % who would recommend the program to a friend

Group	Value	95% CI
Self-directed + Coached Combined	8

Change in Weight Secondary · Baseline and follow-up assessment (20-weeks after randomization)

Changes between baseline and 20-weeks later (end of intervention)

Group	Value	95% CI
Coached	-7.3	-16.0 – 1.5
Self-directed	1.3	-2.8 – 5.3

Change in 6-minute Walk Distance Secondary · Baseline and at follow-up assessment (20-weeks after randomization)

Change in 6-minute walk distance (ft) from baseline to follow-up

Group	Value	95% CI
Coached	185.4	-31.9 – 402.8
Self-directed	43.2	-69.1 – 155.4

Sponsor's own description

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:

1. test the feasibility of recruiting overweight/obese individuals with LEA into a randomized trial;
2. assess whether the intervention can be delivered with high fidelity, and
3. evaluate whether the intervention is acceptable to and safe as determined by participant feedback, participation and retention for outcome measures.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.