NCT02656693: PROPS

Integrating Online Weight Management With Primary Care Support

Completed NA Results posted Last updated 5 November 2020

What this trial tests

NA trial testing Online weight management program in Obesity in 840 participants. Completed in 8 May 2019.

Timeline

19 July 2016

Primary endpoint
8 November 2018

8 May 2019

Quick facts

Lead sponsor	Brigham and Women's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	840
Start date	19 July 2016
Primary completion	8 November 2018
Estimated completion	8 May 2019
Sites	1 location across United States

Drugs / interventions tested

• Online weight management program
• Population health management support

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

Brigham and Women's Hospital

Who can join

Adults 20 to 70, any sex, with Obesity. 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.

Change in Body Weight at 12 Months Primary · 12 months after the initial primary care visit

change in body weight from enrollment to 12 months

Group	Value	95% CI
Usual Care	-1.2	-2.1 – -0.3
Online Program Only	-1.9	-2.6 – -1.1
Combined Intervention	-3.1	-3.7 – -2.5

Change in Body Weight at 6 Months Secondary · 6 months after the initial primary care visit

change in body weight from enrollment to 6 months

Group	Value	95% CI
Usual Care	-1.0	-1.9 – -0.1
Online Program Only	-2.1	-2.8 – -1.5
Combined Intervention	-2.9	-3.5 – -2.3

Change in Body Weight at 18 Months Secondary · 18 months after the initial primary care visit

change in body weight from enrollment to 18 months

Group	Value	95% CI
Usual Care	-1.9	-2.8 – -1.0
Online Program Only	-1.1	-2.0 – -0.3
Combined Intervention	-2.8	-3.5 – -2.0

Percent Weight Change at 6 Months Secondary · 6 months after the initial primary care visit

Percent weight change from enrollment to 6 months

Group	Value	95% CI
Usual Care	-1.0	-1.9 – 0.03
Online Program Only	-2.0	-3.1 – -0.9
Combined Intervention	-2.8	-3.8 – -1.8

Percent Weight Change at 12-Months Secondary · 12 months after the initial primary care visit

Percent weight change from enrollment to 12 months

Group	Value	95% CI
Usual Care	-1.4	-2.3 – -0.6
Online Program Only	-1.9	-2.8 – -1.0
Combined Intervention	-3.0	-3.8 – -2.1

Percent Weight Change at 18-Months Secondary · 18 months after the initial primary care visit

Percent weight change from enrollment to 18 months

Group	Value	95% CI
Usual Care	-1.9	-2.9 – -0.9
Online Program Only	-0.9	-2.0 – 0.2
Combined Intervention	-2.6	-3.6 – -1.5

Percent of Patients With at Least 5% Weight Loss at 6 Months Secondary · 6-months after the initial primary care visit

Percent of Patients With at Least 5% Weight Loss from enrollment to 6 months

Group	Value	95% CI
Usual Care	13.4	7.8 – 19.0
Online Program Only	22.1	14.2 – 30.0
Combined Intervention	29.5	21.4 – 37.5

Percent of Patients With at Least 5% Weight Loss at 12-months Secondary · 12 months after the initial primary care visit

Percent of Patients with at least 5% weight loss from enrollment to 12 months

Group	Value	95% CI
Usual Care	14.9	10.2 – 19.6
Online Program Only	20.8	14.5 – 27.2
Combined Intervention	32.3	25.8 – 38.8

Percent of Patients With at Least 5% Weight Loss at 18 Months Secondary · 18-months after the initial primary care visit

Percent of Patients With at least 5% weight loss from enrollment to 18 months

Group	Value	95% CI
Usual Care	20.9	14.3 – 27.6
Online Program Only	19.9	12.5 – 27.3
Combined Intervention	31.3	23.0 – 39.6

Changes in Self-efficacy Around Weight Loss at 12 Months Secondary · 12 months after initial primary care visit

Changes in self-efficacy around weight loss at 12 months Self-efficacy will be assessed by asking patients to rate their confidence in their ability to lose weight on a scale from 1 ("not at all confident") to 10 ("very confident"). A rank of 1-7 reflects low self-efficacy, while 8-10 reflects high self-efficacy based on Bandura's theory of self-efficacy.

Group	Value	95% CI
Usual Care	-0.7	-1.1 – -0.3
Online Program Only	-0.4	-0.9 – 0.07
Combined Intervention	0.5	0.06 – 0.9

Changes in Systolic Blood Pressure Secondary · 12 months after the initial primary care visit

changes in systolic blood pressure (BP) from enrollment to 12 months

Group	Value	95% CI
Usual Care	-0.9	-2.8 – 1.0
Online Program Only	-3.0	-5.4 – -0.6
Combined Intervention	-0.2	-2.3 – 1.9

Changes in Diastolic Blood Pressure Secondary · 12 months after the initial primary care visit

changes in diastolic blood pressure (BP) from enrollment to 12 months

Group	Value	95% CI
Usual Care	-1.0	-2.2 – 0.3
Online Program Only	-2.2	-3.8 – -0.7
Combined Intervention	-1.1	-2.4 – 0.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Usual Care

Serious: 12/326 (4%)

Deaths: 0/326

Online Program Only

Serious: 11/216 (5%)

Deaths: 0/216

Combined Intervention

Serious: 18/298 (6%)

Deaths: 1/298

Serious adverse events (23 terms)

Reaction	System	Usual Care	Online Program Only	Combined Intervention
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Coronary artery bypass grafting (CABG)	Cardiac disorders	—	—	—
Heart attack	Cardiac disorders	—	—	—
Pancreatitis	Endocrine disorders	—	—	—
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Pulmonary embolism	Vascular disorders	—	—	—
Angina	Cardiac disorders	—	—	—
Coronary arteriogram	Cardiac disorders	—	—	—
Dyspnea	Cardiac disorders	—	—	—
GI bleed	Gastrointestinal disorders	—	—	—
Endocarditis	Infections and infestations	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Headache	Nervous system disorders	—	—	—
Seizure	Nervous system disorders	—	—	—
Alcohol use disorder	Psychiatric disorders	—	—	—
Depression	Psychiatric disorders	—	—	—
Brain surgery	Surgical and medical procedures	—	—	—
Spinal stenosis of lumbar region	Surgical and medical procedures	—	—	—
Transient ischemic attack	Vascular disorders	—	—	—

Most-reported serious reactions: Prostate cancer, Breast cancer, Coronary artery bypass grafting (CABG), Heart attack, Pancreatitis, Bladder cancer, Pulmonary embolism, Angina.

Data from ClinicalTrials.gov NCT02656693 adverse events section.

Sponsor's own description

The goal of this project is to adapt an evidence-based online weight management program and integrate it with population management support from primary care practices. Investigators then will conduct a three-arm, cluster-randomized trial to compare the effectiveness of 1) the combined intervention (online weight management program plus population management support) with 2) the stand-alone online weight management program and with 3) usual care, among overweight and obese primary care patients with type 2 diabetes or hypertension. The specific aims are:

1. a. To adapt an online weight management program and integrate it with population management support, incorporating input from patients, primary care clinicians, and other stakeholders; afterward, investigators will acquire feedback on the positive and negative aspects of the intervention.

b. To compare the effectiveness of the combined intervention (online weight management program plus population management support) with the stand-alone online program and with usual care.

Hypothesis 1: The combined intervention will lead to greater weight loss at 12 months compared with the stand-alone online program and with usual care.
2. To identify mediators of the combined intervention and the stand-alone online program.

Hypothesis 2: The effects of the combined intervention and the stand-alone online program on weight loss will be mediated by patients' level of engagement, changes in self-efficacy, and changes in diet and physical activity.
3. To explore whether the effectiveness of the combined intervention and the stand-alone weight management program varies by patient characteristics.

Hypothesis 3: The interventions will be more effective among patients who are younger, white, and higher socioeconomic status, although the population management strategy may help to reduce these differences.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of an Online Weight Management Program Integrated With Population Health Management on Weight Change: A Randomized Clinical Trial.
   Baer HJ, Rozenblum R, De La Cruz BA, Orav EJ, et al · · 2020 · cited 38× · PMID 33141209 · DOI 10.1001/jama.2020.18977
2. Integrating an online weight management program with population health management in primary care: Design, methods, and baseline data from the PROPS randomized controlled trial (Partnerships for Reducing Overweight and Obesity with Patient-centered Strategies).
   Baer HJ, De La Cruz BA, Rozenblum R, Nolido NV, et al · · 2020 · cited 7× · PMID 32428586 · DOI 10.1016/j.cct.2020.106026
3. Primary Care Patients' and Providers' Perspectives about an Online Weight Management Program: a Qualitative Study.
   Rozenblum R, De La Cruz BA, Nolido NV, Adighibe I, et al · · 2019 · cited 6× · PMID 31152361 · DOI 10.1007/s11606-019-05022-6
4. Primary care patients' and providers' perspectives about an online weight management program integrated with population health management: Post-intervention qualitative results from the PROPS study.
   Rozenblum R, De La Cruz BA, Nolido NV, McNulty S, et al · · 2022 · PMID 37213741 · DOI 10.1016/j.pecinn.2022.100057