Trial Outcomes & Findings for Weight Loss Physical Disabilities (NCT NCT04046471)

Results Overview

Weight will be measured in duplicate with a portable, calibrated digital scale. (Model #PS6600, Befour, Saukville, WI.). For those in a wheelchair, weight will be measured in duplicate using a portable calibrated, digital wheelchair scale (Model MX420, Befour, Saukville, WI.). Participant weight will be calculated as participant + chair weight minus chair weight.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

129 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2025-08-05

Participant Flow

Participant milestones

Participant milestones
Measure	Individual In-Person enhanced Stop Light Diet: Stop light diet enhanced with portion-controlled meals Individual In-Person: Participants will receive a weight loss intervention during individual, at-home visits.	Group Remote enhanced Stop Light Diet: Stop light diet enhanced with portion-controlled meals Group Remote: Participants will receive remotely delivered weight loss in a group setting.
6-month STARTED	63	66
6-month COMPLETED	54	62
6-month NOT COMPLETED	9	4
12-month STARTED	54	62
12-month COMPLETED	49	58
12-month NOT COMPLETED	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Weight Loss Physical Disabilities

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Individual In-Person n=63 Participants enhanced Stop Light Diet: Stop light diet enhanced with portion-controlled meals Individual In-Person: Participants will receive a weight loss intervention during individual, at-home visits.	Group Remote n=66 Participants enhanced Stop Light Diet: Stop light diet enhanced with portion-controlled meals Group Remote: Participants will receive remotely delivered weight loss in a group setting.	Total n=129 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=5 Participants	42 Participants n=7 Participants	90 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	24 Participants n=7 Participants	39 Participants n=5 Participants
Age, Continuous	54.3 years STANDARD_DEVIATION 12.4 • n=5 Participants	55.9 years STANDARD_DEVIATION 14.3 • n=7 Participants	55.1 years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	53 Participants n=7 Participants	103 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=5 Participants	58 Participants n=7 Participants	111 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants	55 Participants n=7 Participants	100 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	63 participants n=5 Participants	66 participants n=7 Participants	129 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Weight will be measured in duplicate with a portable, calibrated digital scale. (Model #PS6600, Befour, Saukville, WI.). For those in a wheelchair, weight will be measured in duplicate using a portable calibrated, digital wheelchair scale (Model MX420, Befour, Saukville, WI.). Participant weight will be calculated as participant + chair weight minus chair weight.

Outcome measures

Outcome measures
Measure	Individual In-Person n=63 Participants enhanced Stop Light Diet: Stop light diet enhanced with portion-controlled meals Individual In-Person: Participants will receive a weight loss intervention during individual, at-home visits.	Group Remote n=66 Participants enhanced Stop Light Diet: Stop light diet enhanced with portion-controlled meals Group Remote: Participants will receive remotely delivered weight loss in a group setting.
Weight Change in kg From Baseline to 6-months	-6.23 kg Standard Deviation 6.70	-8.16 kg Standard Deviation 6.74

SECONDARY outcome

Timeframe: Baseline, 6, 12, and 18 months

Weight will be measured in duplicate with a portable, calibrated digital scale. (Model #PS6600, Befour, Saukville, WI.). For those in a wheelchair, weight will be measured in duplicate using a portable calibrated, digital wheelchair scale (Model MX420, Befour, Saukville, WI.). Participant weight will be calculated as participant + chair weight minus chair weight.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6, 12, and 18 months

Measured in cm around narrowest part of the waist.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6, 12, and 18 months

Obtained with an automated sphygmomanometer (DinaMap ProCare 100, General Electric) using the NHANES blood pressure protocol.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6, 12, and 18 months

Assessed with the SF-36E. The SF-36E measures quality of life on a 0-100 scale with 0 being low quality and 100 being high quality.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Across 18 months

The cost of both the IH and GR interventions will be calculated along with the cost per additional kg of weight loss.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6, 12, and 18 months

Will be assessed using photo-assisted food records over 4 consecutive days (3 wk. days and 1 wk. end day) starting the weekend prior to scheduled outcome assessments.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6, 12, and 18 months

Assessed using the Physical Activity and Disability Survey (PADS). The PADS is a semi-structured interview that includes subscales for exercise, leisure time PA, household activity, and inactivity (sleeping, TV, computer use).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Across 18 months

Expressed as the percentage of possible sessions attended

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Across 18 months

The percentage of prescribed monitoring days completed across 18 mos.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6, 12, and 18 months

Assessed using the Weight Efficacy Lifestyle Scale. This scale has participants rate a question from 1 to 10 with 1 being "Not at all confident" and 10 being "Very confident."

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6, 12, and 18 months

Assessed using the Barriers to Exercise for Disabled Person. Individuals are asked a question relating to a specific exercise barrier and if it has limited their participation in the past three months. If they answer yes, they are asked to rate the limitation of that barrier on a scale of 1 to 5 with 1 being the least and 5 being the most limiting. Scores are calculated using weighted sums of the items.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6, 12, and 18 months

Assessed using the Three-Factor Eating Inventory, a widely-used measure of eating behavior (restraint, disinhibition, hunger). Participant is asked a question and to rate how they feel on a 1-4 scale with 1 being "definitely false" and 4 being "definitely true."

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6, 12, and 18 months

Social support for both exercise and dietary habits will be assessed using the Social Support and Exercise/Diet Survey. This survey utilizes questions focusing on support by peers and family members that participants answer using a 1-5 rating with 1 being "no support" and 5 being "very supportive."

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6, 12, and 18 months

Sleep Quality will be assessed using The Pittsburgh Sleep Quality Index. Participants answer open-ended questions as well as questions on a 0-3 scale. Seven component scores are tallied using provided measures, and a global sum of "5"or greater on all seven components indicates a "poor" sleeper.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6, 12, and 18 months

Medication name/frequency/amount will be collected by participant self-report

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3-12 months

Energy expenditure of the remote sessions will be assessed in a volunteer sample using a previously validated portable, open-circuit indirect calorimeter (Cosmed, Italy) which measures breath-by-breath ventilation, expired oxygen, and carbon dioxide.

Outcome measures

Outcome data not reported

Adverse Events

Individual In-Person

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Group Remote

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Individual In-Person n=63 participants at risk enhanced Stop Light Diet: Stop light diet enhanced with portion-controlled meals Individual In-Person: Participants will receive a weight loss intervention during individual, at-home visits.	Group Remote n=66 participants at risk enhanced Stop Light Diet: Stop light diet enhanced with portion-controlled meals Group Remote: Participants will receive remotely delivered weight loss in a group setting.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	0.00% 0/63 • Baseline to 6-months	1.5% 1/66 • Number of events 1 • Baseline to 6-months
Immune system disorders Lupus Flare	1.6% 1/63 • Number of events 1 • Baseline to 6-months	0.00% 0/66 • Baseline to 6-months
Respiratory, thoracic and mediastinal disorders Pneumonia	1.6% 1/63 • Number of events 1 • Baseline to 6-months	0.00% 0/66 • Baseline to 6-months
Respiratory, thoracic and mediastinal disorders Smoke Inhalation	1.6% 1/63 • Number of events 1 • Baseline to 6-months	0.00% 0/66 • Baseline to 6-months
Vascular disorders Stroke	1.6% 1/63 • Number of events 1 • Baseline to 6-months	0.00% 0/66 • Baseline to 6-months
General disorders Heart Failure Complications	1.6% 1/63 • Number of events 1 • Baseline to 6-months	0.00% 0/66 • Baseline to 6-months
Cardiac disorders Aortic Stenosis	0.00% 0/63 • Baseline to 6-months	1.5% 1/66 • Number of events 1 • Baseline to 6-months
Renal and urinary disorders Bladder Obstruction	1.6% 1/63 • Number of events 1 • Baseline to 6-months	0.00% 0/66 • Baseline to 6-months

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joseph Donnelly

University of Kansas Medical Center

Phone: 785-864-1687

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place