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Does a combined intervention, including an online weight management program integrated with population health management (additional support and outreach from nonclinical staff), increase weight loss at 12 months among primary care patients compared with the online program only and usual care?
In this cluster randomized trial of 840 patients with overweight or obesity and a diagnosis of hypertension or type 2 diabetes, the mean weight loss at 12 months was 1.2 kg in the usual care group, 1.9 kg in the online program only group, and 3.1 kg in the combined online program with population health management group. The difference in weight loss between the combined intervention group and either the usual care group or the online program only group was statistically significant.
Combining population health management with an online program resulted in a small but statistically significant greater amount of weight loss at 12 months compared with usual care or the online program only.
Online programs may help with weight loss but have not been widely implemented in routine primary care.
To compare the effectiveness of a combined intervention, including an online weight management program plus population health management, with the online program only and with usual care.
Design, Setting, and Participants
Cluster randomized trial with enrollment from July 19, 2016, through August 10, 2017, at 15 primary care practices in the US. Eligible participants had a scheduled primary care visit and were aged 20 to 70 years, had a body mass index between 27 and less than 40, and had a diagnosis of hypertension or type 2 diabetes. Follow-up ended on May 8, 2019.
Participants in the usual care group (n = 326) were mailed general information about weight management. Participants in the online program only group (n = 216) and the combined intervention group (n = 298) were registered for the online program. The participants in the combined intervention group also received weight-related population health management, which included additional support from nonclinical staff who monitored their progress in the online program and conducted periodic outreach.
Main Outcomes and Measures
The primary outcome was weight change at 12 months based on measured weights recorded in the electronic health record. Weight change at 18 months was a secondary outcome.
Among the 840 participants who enrolled (mean age, 59.3 years [SD, 8.6 years]; 60% female; 76.8% White), 732 (87.1%) had a recorded weight at 12 months and the missing weights for the remaining participants were imputed. There was a significant difference in weight change at 12 months by group with a mean weight change of –1.2 kg (95% CI, –2.1 to –0.3 kg) in the usual care group, –1.9 kg (95% CI, –2.6 to –1.1 kg) in the online program only group, and –3.1 kg (95% CI, –3.7 to –2.5 kg) in the combined intervention group (P < .001). The difference in weight change between the combined intervention group and the usual care group was –1.9 kg (97.5% CI, –2.9 to –0.9 kg; P < .001) and the difference between the combined intervention group and the online program only group was –1.2 kg (95% CI, –2.2 to –0.3 kg; P = .01). At 18 months, the mean weight change was –1.9 kg (95% CI, –2.8 to –1.0 kg) in the usual care group, –1.1 kg (95% CI, –2.0 to –0.3 kg) in the online program only group, and –2.8 kg (95% CI, –3.5 to –2.0 kg) in the combined intervention group (P < .001).
Conclusions and Relevance
Among primary care patients with overweight or obesity and hypertension or type 2 diabetes, combining population health management with an online program resulted in a small but statistically significant greater weight loss at 12 months compared with usual care or the online program only. Further research is needed to understand the generalizability, scalability, and durability of these findings.
ClinicalTrials.gov Identifier: NCT02656693
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Corresponding Author: Heather J. Baer, ScD, Division of General Internal Medicine and Primary Care, Brigham and Women’s Hospital, 1620 Tremont St, Boston, MA 02120 (firstname.lastname@example.org).
Accepted for Publication: September 8, 2020.
Author Contributions: Dr Baer had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Baer, Rozenblum, Metzler, McManus, Halperin, Aronne, Block, Bates.
Acquisition, analysis, or interpretation of data: Baer, De La Cruz, Orav, Wien, Nolido, Metzler, McManus, Halperin, Minero, Bates.
Drafting of the manuscript: Baer, Rozenblum, De La Cruz, Wien, Block.
Critical revision of the manuscript for important intellectual content: Baer, Rozenblum, Orav, Wien, Nolido, Metzler, McManus, Halperin, Aronne, Minero, Bates.
Statistical analysis: Baer, Orav, Wien.
Obtained funding: Baer, Bates.
Administrative, technical, or material support: Baer, Rozenblum, De La Cruz, Nolido, Metzler, McManus, Minero, Block, Bates.
Supervision: Baer, Halperin, Aronne, Bates.
Conflict of Interest Disclosures: Dr Rozenblum reported having an equity interest in Hospitech Respiration Ltd, which makes Airway Management Solutions. Dr Halperin reported receiving cash compensation and equity from Form Health Inc. Dr Aronne reported receiving consulting fees from and serving on advisory boards for Jamieson Laboratories, Boehringer Ingelheim, Pfizer, Novo Nordisk, Real Appeal, Janssen Pharmaceuticals, and Gelesis; receiving research funding from Aspire Bariatrics, Allurion, Eisai, Eli Lilly, AstraZeneca, Gelesis, Janssen Pharmaceuticals, and Novo Nordisk; having an equity interest in Intellihealth/BMIQ, ERX, Zafgen, Gelesis, MYOS, and Jamieson Laboratories; and serving on the board of directors for MYOS, Intellihealth/BMIQ, and Jamieson Laboratories. Ms Minero reported being employed and having an equity interest in Intellihealth/BMIQ. Dr Bates reported serving as a consultant for EarlySense, which makes patient safety monitoring systems; receiving cash compensation from CDI (Negev) Ltd, which is a not-for-profit incubator for health information technology start-ups; having equity interest in ValeraHealth (which makes software to help patients with chronic diseases), in Clew (which makes software to support clinical decision-making in intensive care), and in MDClone (which takes clinical data and produces deidentified versions of it); and receiving research funding from IBM Watson Health. No other disclosures were reported.
Funding/Support: The research was funded through award 14-092-1758 from the Patient-Centered Outcomes Research Institute (PCORI).
Role of the Funder/Sponsor: PCORI gave input on the design and conduct of the study, but all final decisions were made by the investigators. PCORI was not involved in the collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: The statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of PCORI, its board of governors, or its methodology committee.
Data Sharing Statement: See Supplement 3.
Additional Contributions: We thank the study participants, the physicians, and all of the other employees working at the Brigham and Women’s Hospital [BWH] primary care practices. We also thank the population health managers: Ihorma Breneus, RN (lead population health manager; worked at BWH during the study and was compensated for being the lead), Mary Merriam, RN (works at BWH), Charles Morris, MD (works at BWH), and Clark Davis, BS (works at BWH as a research assistant, created Figure 2, and was compensated for this work). We also thank the members of the patient and family advisory council for their support and partnership through all stages of this project and who received compensation for their advisory roles: Renee Blocker, BA, Alison Olson, BA, and Mary Reynolds, MSN.
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