Effect of Telehealth Extended Care for Maintenance of Weight Loss in Rural US Communities: A Randomized Clinical Trial

Abstract

Importance: Lifestyle interventions for obesity produce reductions in body weight that can decrease risk for diabetes and cardiovascular disease but are limited by suboptimal maintenance of lost weight and inadequate dissemination in low-resource communities.

Objective: To evaluate the effectiveness of extended care programs for obesity management delivered remotely in rural communities through the US Cooperative Extension System.

Design, setting, and participants: This randomized clinical trial was conducted from October 21, 2013, to December 21, 2018, in Cooperative Extension Service offices of 14 counties in Florida. A total of 851 individuals were screened for participation; 220 individuals did not meet eligibility criteria, and 103 individuals declined to participate. Of 528 individuals who initiated a 4-month lifestyle intervention, 445 qualified for randomization. Data were analyzed from August 22 to October 21, 2019.

Interventions: Participants were randomly assigned to extended care delivered via individual or group telephone counseling or an education control program delivered via email. All participants received 18 modules with posttreatment recommendations for maintaining lost weight. In the telephone-based interventions, health coaches provided participants with 18 individual or group sessions focused on problem solving for obstacles to the maintenance of weight loss.

Main outcomes and measures: The primary outcome was change in body weight from the conclusion of initial intervention (month 4) to final follow-up (month 22). An additional outcome was the proportion of participants achieving at least 10% body weight reduction at follow-up.

Results: Among 445 participants (mean [SD] age, 55.4 [10.2] years; 368 [82.7%] women; 329 [73.9%] white), 149 participants (33.5%) were randomized to individual telephone counseling, 143 participants (32.1%) were randomized to group telephone counseling, and 153 participants (34.4%) were randomized to the email education control. Mean (SD) baseline weight was 99.9 (14.6) kg, and mean (SD) weight loss after the initial intervention was 8.3 (4.9) kg. Mean weight regains at follow-up were 2.3 (95% credible interval [CrI], 1.2-3.4) kg in the individual telephone counseling group, 2.8 (95% CrI, 1.4-4.2) kg for the group telephone counseling group, and 4.1 (95% CrI, 3.1-5.0) kg for the education control group, with a significantly smaller weight regain observed in the individual telephone counseling group vs control group (posterior probability >.99). A larger proportion of participants in the individual telephone counseling group achieved at least 10% weight reductions (31.5% [95% CrI, 24.1%-40.0%]) than in the control group (19.1% [95% CrI, 14.1%-24.9%]) (posterior probability >.99).

Conclusions and relevance: This randomized clinical trial found that providing extended care for obesity management in rural communities via individual telephone counseling decreased weight regain and increased the proportion of participants who sustained clinically meaningful weight losses.

Trial registration: ClinicalTrials.gov Identifier: NCT02054624.

Conflict of interest statement

Conflict of Interest Disclosures: Drs Perri, Daniels, Ross, Janicke, Martin, Dhara, Bobroff, and Befort reported receiving grants from the National Institutes of Health during the conduct of the study. Dr Limacher reported receiving grants from National Institutes of Health during the conduct of the study and having a consulting relationship with Lungpacer Medical. Dr Befort reported receiving grants from the National Institutes of Health and Patient Centered Outcomes Research Institute. No other disclosures were reported.

Figures

Figure 1.. Diagram of Participant Flow

Figure 2.. Changes in Body Weight by Group