Effect of an Online Weight Management Program Integrated With Population Health Management on Weight Change: A Randomized Clinical Trial

Abstract

Importance: Online programs may help with weight loss but have not been widely implemented in routine primary care.

Objective: 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.

Interventions: 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.

Results: 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.

Trial registration: ClinicalTrials.gov Identifier: NCT02656693.

Conflict of interest statement

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.

Figures

Figure 1.. Flow of Participants

BMIQ (Intellihealth Inc) is the name of the online weight management program. aThe most common reasons for exclusion were the body mass index was out of the inclusion range (n = 179), lost 5% or greater of body weight within last 6 months (n = 98), did not have hypertension or type 2 diabetes (n = 71), or had a severe mental health condition (n = 63). bAt 18 months, weight was not recorded for 44 participants in the combined intervention group, 43 participants in the online program only group, and 66 participants in the usual care group. cFully conditional specification multiple imputation with 25 imputations was used to estimate missing weights and other outcomes and covariates and was based on available data for 91 patient variables.

Figure 2.. Mean Weight Change at 6, 12, and 18 Months

The boxplots were created using the raw data from the first round of multiple imputation. The boxes are staggered horizontally around each time point to avoid superimposition. The boxes indicate the 25th and 75th percentiles of the data, and the horizontal lines within the boxes indicate the median values. The whiskers indicate the highest and lowest values within 1.5 times the interquartile range and the dots outside the whiskers are outliers. The lines show the mean weight change at each time point (indicated by the dots within the boxes) from repeated-measures linear regression models adjusted for age, sex, race/ethnicity, educational level, and medical conditions (type 2 diabetes, hypertension, and hyperlipidemia). Clinic type (community-based clinic, hospital-based, or community health center) was included as a fixed effect. Clinic, physician, and patient were included as random effects. All 840 patients were included in the models. Fully conditional specification multiple imputation with 25 imputations was used to estimate missing weights and other outcomes and covariates and was based on available data for 91 patient variables. The estimates and 95% CIs for the mean weight change from the models appear in Table 2.