Trial Outcomes & Findings for Computer-Based Weight Maintenance in Primary Care (NCT NCT01946191)

NCT ID: NCT01946191

Last Updated: 2020-11-02

Results Overview

Weight (kg), change from baseline, Estimate (SE) \[95% confidence interval\]

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 194 participants
• Primary outcome timeframe: Baseline to 24 months
• Results posted on: 2020-11-02

Participant Flow

Participant milestones

Measure	Continued Group * 24 months of personalized coaching through the EHR patient portal, with 24 scheduled contacts * Online self-monitoring * Real-time updates to primary care physicians	Tracking Group Online self-monitoring
Allocation STARTED	98	96
Allocation COMPLETED	97	95
Allocation NOT COMPLETED	1	1
Follow-Up, 24-mo Endpoint STARTED	97	95
Follow-Up, 24-mo Endpoint COMPLETED	80	77
Follow-Up, 24-mo Endpoint NOT COMPLETED	17	18
Primary Outcome Analysis STARTED	98	95
Primary Outcome Analysis COMPLETED	80	77
Primary Outcome Analysis NOT COMPLETED	18	18

Reasons for withdrawal

Measure	Continued Group * 24 months of personalized coaching through the EHR patient portal, with 24 scheduled contacts * Online self-monitoring * Real-time updates to primary care physicians	Tracking Group Online self-monitoring
Allocation Did not complete orientation	1	1
Follow-Up, 24-mo Endpoint Withdrawal by Subject	4	2
Follow-Up, 24-mo Endpoint Protocol Violation	0	1
Follow-Up, 24-mo Endpoint Lost to Follow-up	13	15

Baseline Characteristics

Computer-Based Weight Maintenance in Primary Care

Baseline characteristics by cohort

Measure	Coaching Group n=98 Participants Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment	Tracking Group n=96 Participants Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record	Total n=194 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	84 Participants n=5 Participants	75 Participants n=7 Participants	159 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	21 Participants n=7 Participants	35 Participants n=5 Participants
Age, Continuous	53.3 years STANDARD_DEVIATION 12 • n=5 Participants	53.5 years STANDARD_DEVIATION 12.4 • n=7 Participants	53.4 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	67 Participants n=5 Participants	76 Participants n=7 Participants	143 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	20 Participants n=7 Participants	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	88 Participants n=5 Participants	83 Participants n=7 Participants	171 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 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	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) White	88 Participants n=5 Participants	83 Participants n=7 Participants	171 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	98 Participants n=5 Participants	96 Participants n=7 Participants	194 Participants n=5 Participants
Non-smoker	95 Participants n=5 Participants	94 Participants n=7 Participants	189 Participants n=5 Participants
Education post high school	95 Participants n=5 Participants	90 Participants n=7 Participants	185 Participants n=5 Participants
Weight	88.2 kg STANDARD_DEVIATION 18.7 • n=5 Participants	83.3 kg STANDARD_DEVIATION 19.2 • n=7 Participants	85.8 kg STANDARD_DEVIATION 19.1 • n=5 Participants
Waist circumference	99.7 cm STANDARD_DEVIATION 13.9 • n=5 Participants	96.2 cm STANDARD_DEVIATION 16.8 • n=7 Participants	97.9 cm STANDARD_DEVIATION 15.5 • n=5 Participants
Any moderate physical activity	93 Participants n=5 Participants	92 Participants n=7 Participants	185 Participants n=5 Participants
Any vigorous physical activity	59 Participants n=5 Participants	60 Participants n=7 Participants	119 Participants n=5 Participants
High cholesterol	46 Participants n=5 Participants	37 Participants n=7 Participants	83 Participants n=5 Participants
Hypertension	56 Participants n=5 Participants	40 Participants n=7 Participants	96 Participants n=5 Participants
Arthritis (Knee and/or Hip)	30 Participants n=5 Participants	28 Participants n=7 Participants	58 Participants n=5 Participants
Diabetes or Pre-Diabetes	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Anxiety/Depression	30 Participants n=5 Participants	23 Participants n=7 Participants	53 Participants n=5 Participants
Systolic blood pressure	124.7 mm Hg STANDARD_DEVIATION 14.2 • n=5 Participants	121.6 mm Hg STANDARD_DEVIATION 13.0 • n=7 Participants	123.2 mm Hg STANDARD_DEVIATION 13.7 • n=5 Participants
Diastolic blood pressure	75.4 mm Hg STANDARD_DEVIATION 8.9 • n=5 Participants	72.7 mm Hg STANDARD_DEVIATION 10.1 • n=7 Participants	74.0 mm Hg STANDARD_DEVIATION 9.6 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 24 months

Weight (kg), change from baseline, Estimate (SE) [95% confidence interval]

Outcome measures

Measure	Coaching Group n=80 Participants Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment	Tracking Group n=77 Participants Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record
Body Weight	2.07 kg Standard Error 0.62	4.93 kg Standard Error 0.63

SECONDARY outcome

Timeframe: Baseline to 24-months

Body Mass Index, change from baseline, Estimate (SE) [95% CI]

Outcome measures

Measure	Coaching Group n=80 Participants Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment	Tracking Group n=77 Participants Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record
BMI	0.80 kg/m^2 Standard Error 0.22	1.80 kg/m^2 Standard Error 0.23

SECONDARY outcome

Timeframe: Baseline to 24-months

Waist circumference (cm), change from baseline, Estimate (SE) [95% CI]

Outcome measures

Measure	Coaching Group n=80 Participants Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment	Tracking Group n=77 Participants Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record
Waist Circumference (cm)	1.34 centimeters Standard Error 0.73	3.83 centimeters Standard Error 0.74

SECONDARY outcome

Timeframe: Baseline to 24-months

Participants maintaining 5% weight loss, No (%)

Outcome measures

Measure	Coaching Group n=80 Participants Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment	Tracking Group n=77 Participants Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record
Maintenance of 5% Weight Loss	79 Participants	73 Participants

SECONDARY outcome

Timeframe: Baseline to 24 months

Pedometer steps per day, change from baseline, Estimate (SE) [95% CI]

Outcome measures

Measure	Coaching Group n=80 Participants Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment	Tracking Group n=77 Participants Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record
Pedometer Steps Per Day	-335.83 Steps per day Standard Error 302.24	-750.68 Steps per day Standard Error 302.76

SECONDARY outcome

Timeframe: Baseline to 24-months

Physical Component score, Estimate (SE) [95% CI] The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

Outcome measures

Measure	Coaching Group n=80 Participants Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment	Tracking Group n=79 Participants Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record
Physical Component Score (SF-36)	-1.95 score on a scale Standard Error 0.77	-3.47 score on a scale Standard Error 0.79

SECONDARY outcome

Timeframe: Baseline to 24-months

Mental Component score, Estimate (SE) [95% CI] The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

Outcome measures

Measure	Coaching Group n=80 Participants Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment	Tracking Group n=77 Participants Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record
Mental Component Score (SF-36)	-2.49 score Standard Error 0.89	-2.98 score Standard Error 0.09

SECONDARY outcome

Timeframe: Baseline to 24 months

WOMAC function score, change from baseline, Estimate (SE) [95% CI] Western Ontario and McMaster Universities Osteoarthritis Index function scale WOMAC function scores are given on a best-to-worst scale of 0-to-100

Outcome measures

Measure	Coaching Group n=80 Participants Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment	Tracking Group n=77 Participants Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record
WOMAC Function Score	3.20 score on a scale Standard Error 1.17	1.22 score on a scale Standard Error 1.19

SECONDARY outcome

Timeframe: Baseline to 24-months

Systolic Blood Pressure (mmHg), change from baseline, Estimate (SE) [95% CI]

Outcome measures

Measure	Coaching Group n=80 Participants Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment	Tracking Group n=77 Participants Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record
Systolic Blood Pressure	4.63 mmHg Standard Error 1.49	8.44 mmHg Standard Error 1.53

SECONDARY outcome

Timeframe: Baseline to 24-months

Diastolic Blood Pressure (mmHg), change from baseline, Estimate (SE) [95% CI]

Outcome measures

Measure	Coaching Group n=80 Participants Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment	Tracking Group n=77 Participants Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record
Diastolic Blood Pressure	2.78 mmHg Standard Error 0.95	4.58 mmHg Standard Error 0.98

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months and 30 Months

PCP satisfaction and perceived usefulness of a technologic intervention to improve self-management of patients' weight will be assessed at the end of the first year (12 months) and at the end of the study (30 months).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months and 30 Months

Patient satisfaction and perceived usefulness of a technologic intervention to improve self-management of weight will be assessed at the end of the first year (12 months) and the end of the study (30 months).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 24-months

Dietary score, change from baseline, Estimate (SE) [95% CI] Dietary score scale is 0-7. Lower scores indicate a diet that is less heart-healthy.

Outcome measures

Measure	Coaching Group n=80 Participants Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment	Tracking Group n=77 Participants Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record
Dietary Score	-0.21 score on a scale Standard Error 0.14	-0.23 score on a scale Standard Error 0.15

Adverse Events

Continued Group

Serious events: 0 serious events

Other events: 48 other events

Deaths: 0 deaths

Tracking Group

Serious events: 0 serious events

Other events: 67 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Continued Group n=98 participants at risk Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment	Tracking Group n=96 participants at risk Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record
General disorders Severe events	10.2% 10/98 • Number of events 10 • 24-months For adverse medical events, the following guidelines were used to describe severity. * Mild * Moderate * Severe Participants were asked about any adverse medical events that might have affected their participation in usual daily activities at each follow-up assessment and self-rated the severity of the event (as opposed to a formal adjudication process).	20.8% 20/96 • Number of events 20 • 24-months For adverse medical events, the following guidelines were used to describe severity. * Mild * Moderate * Severe Participants were asked about any adverse medical events that might have affected their participation in usual daily activities at each follow-up assessment and self-rated the severity of the event (as opposed to a formal adjudication process).
General disorders Moderate	28.6% 28/98 • Number of events 28 • 24-months For adverse medical events, the following guidelines were used to describe severity. * Mild * Moderate * Severe Participants were asked about any adverse medical events that might have affected their participation in usual daily activities at each follow-up assessment and self-rated the severity of the event (as opposed to a formal adjudication process).	34.4% 33/96 • Number of events 33 • 24-months For adverse medical events, the following guidelines were used to describe severity. * Mild * Moderate * Severe Participants were asked about any adverse medical events that might have affected their participation in usual daily activities at each follow-up assessment and self-rated the severity of the event (as opposed to a formal adjudication process).
General disorders Mild	10.2% 10/98 • Number of events 10 • 24-months For adverse medical events, the following guidelines were used to describe severity. * Mild * Moderate * Severe Participants were asked about any adverse medical events that might have affected their participation in usual daily activities at each follow-up assessment and self-rated the severity of the event (as opposed to a formal adjudication process).	14.6% 14/96 • Number of events 14 • 24-months For adverse medical events, the following guidelines were used to describe severity. * Mild * Moderate * Severe Participants were asked about any adverse medical events that might have affected their participation in usual daily activities at each follow-up assessment and self-rated the severity of the event (as opposed to a formal adjudication process).

Additional Information

Dr. Molly Conroy

University of Utah

Phone: 801-581-8310

Email: Molly.Conroy@hsc.utah.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place