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

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.

Cost-Effectiveness of Three Doses of a Behavioral Intervention to Prevent or Delay Type 2 Diabetes in Rural Areas.

BACKGROUND: Rural Americans have higher prevalence of obesity and type 2 diabetes (T2D) than urban populations and more limited access to behavioral programs to promote healthy lifestyle habits. Descriptive evidence from the Rural Lifestyle Intervention Treatment Effectiveness trial delivered through local cooperative extension service offices in rural areas previously identified that behavioral modification with both nutrition education and coaching resulted in a lower program delivery cost per kilogram of weight loss maintained at 2-years compared with an education-only comparator intervention. OBJECTIVE: This analysis extended earlier Rural Lifestyle Intervention Treatment Effectiveness trial research regarding weight loss outcomes to assess whether nutrition education with behavioral coaching delivered through cooperative extension service offices is cost-effective relative to nutrition education only in reducing T2D cases in rural areas. DESIGN: A cost-utility analysis was conducted. PARTICIPANTS/SETTING: Trial participants (n=317) from June 2008 through June 2014 were adults residing in rural Florida counties with a baseline body mass index between 30 and 45, but otherwise identified as healthy. INTERVENTION: Trial participants were randomly assigned to low, moderate, or high doses of behavioral coaching with nutrition education (ie, 16, 32, or 48 sessions over 24 months) or a comparator intervention that included 16 sessions of nutrition education without coaching. Participant glycated hemoglobin level was measured at baseline and the end of the trial to assess T2D status. MAIN OUTCOME MEASURES: T2D categories by treatment arm were used to estimate participants' expected annual health care expenditures and expected health-related utility measured as quality adjusted life years (ie, QALYs) over a 5-year time horizon. Discounted incremental costs and QALYs were used to calculate incremental cost-effectiveness ratios for each behavioral coaching intervention dose relative to the education-only comparator. STATISTICAL ANALYSES PERFORMED: Using a third-party payer perspective, Markov transition matrices were used to model participant transitions between T2D states. Replications of the individual participant behavior were conducted using Monte Carlo simulation. RESULTS: All three doses of the behavioral coaching intervention had lower expected total costs and higher estimated QALYs than the education-only comparator. The moderate dose behavioral coaching intervention was associated with higher estimated QALYs but was costlier than the low dose; the moderate dose was favored over the low dose with willingness to pay thresholds over $107,895/QALY. The low dose behavioral coaching intervention was otherwise favored. CONCLUSIONS: Because most rural Americans live in counties with cooperative extension service offices, nutrition education with behavioral coaching programs similar to those delivered through this trial may be effective and efficient in preventing or delaying T2D-associated consequences of obesity for rural adults.

Featured Article: Behavior Interventions Addressing Obesity in Rural Settings: The E-FLIP for Kids Trial.

OBJECTIVE: To assess the effectiveness of behavioral parent-only (PO) and family-based (FB) interventions on child weight, dietary intake, glycated hemoglobin, and quality of life in rural settings. METHODS: This study was a three-armed, randomized controlled trial. Participants were children (age 8-12 years) with overweight or obesity and their parents. A FB (n = 88), a PO (n = 78) and a health education condition (HEC) (n = 83) each included 20 group contacts over 1 year. Assessment and treatment contacts occurred at Cooperative Extension Service offices. The main outcome was change in child body mass index z-score (BMIz) from baseline to year 2. RESULTS: Parents in all conditions reported high treatment satisfaction (mean of 3.5 or higher on a 4-point scale). A linear mixed model analysis of change in child BMIz from baseline to year 1 and year 2 found that there were no significant group by time differences in child BMIz (year 2 change in BMIz for FB = -0.03 [-0.1, 0.04], PO = -0.01 [-0.08, 0.06], and HEC = -0.09 [-0.15, -0.02]). While mean attendance across conditions was satisfactory during months 1-4 (69%), it dropped during the maintenance phase (42%). High attendance for the PO intervention was related to greater changes in child BMIz (p < .02). Numerous barriers to participation were reported. CONCLUSION: Many barriers exist that inhibit regular attendance at in-person contacts for many families. Innovative delivery strategies are needed that balance treatment intensity with feasibility and acceptability to families and providers to facilitate broad dissemination in underserved rural settings.ClinicalTrials.gov Identifier: NCT01820338.

Design of the Rural LEAP randomized trial: An evaluation of extended-care programs for weight management delivered via group or individual telephone counseling.

Obesity is a major contributor to the greater prevalence of chronic disease morbidity and mortality observed in rural versus nonrural areas of the U.S. Nonetheless, little research attention has been given to modifying this important driver of rural/urban disparities in health outcomes. Although lifestyle treatments produce weight reductions of sufficient magnitude to improve health, the existing research is limited with respect to the long-term maintenance of treatment effects and the dissemination of services to underserved populations. Recent studies have demonstrated the feasibility of delivering lifestyle programs through the infrastructure of the U.S. Cooperative Extension Service (CES), which has >2900 offices nationwide and whose mission includes nutrition education and health promotion. In addition, several randomized trials have shown that supplementing lifestyle treatment with extended-care programs consisting of either face-to-face sessions or individual telephone counseling can improve the maintenance of weight loss. However, both options entail relatively high costs that inhibit adoption in rural communities. The delivery of extended care via group-based telephone intervention may represent a promising, cost-effective alternative that is well suited to rural residents who tend to be isolated, have heightened concerns about privacy, and report lower quality of life. The Rural Lifestyle Eating and Activity Program (Rural LEAP) is a randomized trial, conducted via CES offices in rural communities, targeted to adults with obesity (n = 528), and designed to evaluate the effectiveness and cost-effectiveness of extended-care programs delivered via group or individual telephone counseling compared to an education control condition on long-term changes in body weight.

Comparative effectiveness of three doses of weight-loss counseling: two-year findings from the rural LITE trial.

OBJECTIVE: To evaluate the effects and costs of three doses of behavioral weight-loss treatment delivered via Cooperative Extension Offices in rural communities. METHODS: Obese adults (N = 612) were randomly assigned to low, moderate, or high doses of behavioral treatment (i.e., 16, 32, or 48 sessions over two years) or to a control condition that received nutrition education without instruction in behavior modification strategies. RESULTS: Two-year mean reductions in initial body weight were 2.9% (95% Credible Interval = 1.7-4.3), 3.5% (2.0-4.8), 6.7% (5.3-7.9), and 6.8% (5.5-8.1) for the control, low-, moderate-, and high-dose conditions, respectively. The moderate-dose treatment produced weight losses similar to the high-dose condition and significantly larger than the low-dose and control conditions (posterior probability > 0.996). The percentages of participants who achieved weight reductions ≥ 5% at two years were significantly higher in the moderate-dose (58%) and high-dose (58%) conditions compared with low-dose (43%) and control (40%) conditions (posterior probability > 0.996). Cost-effectiveness analyses favored the moderate-dose treatment over all other conditions. CONCLUSIONS: A moderate dose of behavioral treatment produced two-year weight reductions comparable to high-dose treatment but at a lower cost. These findings have important policy implications for the dissemination of weight-loss interventions into communities with limited resources.

Comparing Costs of Telephone vs Face-to-Face Extended-Care Programs for the Management of Obesity in Rural Settings.

BACKGROUND: A major challenge after successful weight loss is continuing the behaviors required for long-term weight maintenance. This challenge can be exacerbated in rural areas with limited local support resources. OBJECTIVE: This study describes and compares program costs and cost effectiveness for 12-month extended-care lifestyle maintenance programs after an initial 6-month weight-loss program. DESIGN: We conducted a 1-year prospective randomized controlled clinical trial. PARTICIPANTS/SETTING: The study included 215 female participants age 50 years or older from rural areas who completed an initial 6-month lifestyle program for weight loss. The study was conducted from June 1, 2003 to May 31, 2007. INTERVENTION: The intervention was delivered through local Cooperative Extension Service offices in rural Florida. Participants were randomly assigned to a 12-month extended-care program using either individual telephone counseling (n=67), group face-to-face counseling (n=74), or a mail/control group (n=74). MAIN OUTCOME MEASURES: Program delivery costs, weight loss, and self-reported health status were directly assessed through questionnaires and program activity logs. Costs were estimated across a range of enrollment sizes to allow inferences beyond the study sample. STATISTICAL ANALYSES PERFORMED: Nonparametric and parametric tests of differences across groups for program outcomes were combined with direct program cost estimates and expected value calculations to determine which scales of operation favored alternative formats for lifestyle maintenance. RESULTS: Median weight regain during the intervention year was 1.7 kg for participants in the face-to-face format, 2.1 kg for the telephone format, and 3.1 kg for the mail/control format. For a typical group size of 13 participants, the face-to-face format had higher fixed costs, which translated into higher overall program costs ($420 per participant) when compared with individual telephone counseling ($268 per participant) and control ($226 per participant) programs. Although the net weight lost after the 12-month maintenance program was higher for the face-to-face and telephone programs compared with the control group, the average cost per expected kilogram of weight lost was higher for the face-to-face program ($47/kg) compared with the other two programs (approximately $33/kg for telephone and control). CONCLUSIONS: Both the scale of operations and local demand for programs are important considerations in selecting a delivery format for lifestyle maintenance. In this study, the telephone format had a lower cost but similar outcomes compared with the face-to-face format.

The Extension Family Lifestyle Intervention Project (E-FLIP for Kids): design and methods.

The Extension Family Lifestyle Intervention Project (E-FLIP for Kids) is a three-arm, randomized controlled trial assessing the effectiveness of two behavioral weight management interventions in an important and at-risk population, overweight and obese children and their parents in rural counties. Participants will include 240 parent-child dyads from nine rural counties in north central Florida. Dyads will be randomized to one of three conditions: (a) a Family-Based Behavioral Group Intervention, (b) a Parent-Only Behavioral Group Intervention, and (c) an Education Control Condition. Child and parent participants will be assessed at baseline (month 0), post-treatment (month 12) and follow-up (month 24). Assessment and intervention sessions will be held at Cooperative Extension Service offices within each participating county. The primary outcome measure is change in child BMI z-score. Additional key outcome measures include child body fat, waist circumference, dietary intake, physical activity, blood lipids, blood glucose, blood pressure, physical fitness, quality of life, and program and participants costs. Parent BMI, dietary intake, and physical activity also will be assessed. Randomized controlled trials testing the effectiveness of childhood obesity interventions in real-world community-based settings are extremely valuable, but much too rare. The E-FLIP for Kids trial will evaluate the impact of a community-based intervention delivered to families in rural settings utilizing the existing Cooperative Extension Service network on long-term child behavior, weight status and biological markers of diabetes and early cardiovascular disease. If successful, a Parent-Only intervention program may provide a cost-effective and practical intervention for families in underserved rural communities.

Extended-care programs for weight management in rural communities: the treatment of obesity in underserved rural settings (TOURS) randomized trial.

BACKGROUND: Rural counties in the United States have higher rates of obesity, sedentary lifestyle, and associated chronic diseases than nonrural areas, yet the management of obesity in rural communities has received little attention from researchers. METHODS: Obese women from rural communities who completed an initial 6-month weight-loss program at Cooperative Extension Service offices in 6 medically underserved rural counties (n = 234) were randomized to extended care or to an education control group. The extended-care programs entailed problem-solving counseling delivered in 26 biweekly sessions via telephone or face to face. Control group participants received 26 biweekly newsletters containing weight-control advice. RESULTS: Mean weight at study entry was 96.4 kg. Mean weight loss during the initial 6-month intervention was 10.0 kg. One year after randomization, participants in the telephone and face-to-face extended-care programs regained less weight (mean [SE], 1.2 [0.7] and 1.2 [0.6] kg, respectively) than those in the education control group (3.7 [0.7] kg; P = .03 and .02, respectively). The beneficial effects of extended-care counseling were mediated by greater adherence to behavioral weight-management strategies, and cost analyses indicated that telephone counseling was less expensive than face-to-face intervention. CONCLUSIONS: Extended care delivered either by telephone or in face-to-face sessions improved the 1-year maintenance of lost weight compared with education alone. Telephone counseling constitutes an effective and cost-efficient option for long-term weight management. Delivering lifestyle interventions via the existing infrastructure of the Cooperative Extension Service represents a viable means of adapting research for rural communities with limited access to preventive health services. Trial Registration clinicaltrials.gov Identifier: NCT00201006.

Interactive learning for congregate nutrition site nutrition education: a pilot study.

Older adults who participate in the Older Americans Act Title III-C Elderly Nutrition Program often are at moderate to high nutritional risk. Although nutrition education is a component of the Elderly Nutrition Program, there are numerous barriers to promoting behavior change in older adults. Nutrition education programs targeted to congregate nutrition site participants must address their unique nutritional needs, while engaging them in activities that promote learning and motivate them to make positive behavior changes. This paper describes a pilot study of a theory-driven, five-lesson educational module designed to promote healthful eating behaviors among congregate nutrition site participants through interactive learning.

A new visual tool and technique for nutrition education in the Caribbean

This paper presents a technique and tool for use in the collection of dietary information and for nutrition education among a wide range of clients, including those with low literacy, children, and persons with impaired hearing. The tool is a set of two-dimensional food models that are mounted on cardboard or heavy paper and then laminated. This paper descibes their use for the collection of food frequency data, data on food beliefs and attitudes, and meal planning especially among the Caribbean population. The technique is also useful to assess the effect of nutrition education when used in a pre-test/post-test protocol. The tool and technique are inexpensive and can be used repeatedly.(AU)

A new visual tool and technique for nutrition education in the Caribbean

This paper presents a technique and tool for use in the collection of dietary information and for nutrition education among a wide range of clients, including those with low literacy, children, and persons with impaired hearing. The tool is a set of two-dimensional food models that are mounted on cardboard or heavy paper and then laminated. This paper descibes their use for the collection of food frequency data, data on food beliefs and attitudes, and meal planning especially among the Caribbean population. The technique is also useful to assess the effect of nutrition education when used in a pre-test/post-test protocol. The tool and technique are inexpensive and can be used repeatedly.