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Successful Internet-Based Lifestyle Change Program on Body Weight and Markers of Metabolic Health

Holly R. Wyatt, M.D.,1 Lorraine G. Ogden, Ph.D.,1 Kristen S. Cassic, M.A.,1
Emily A. Hoagland, M.S., R.D.,1 Toni McKinnon, R.N.,2 Natalie Eich, B.S.,2
Vasiliy Chernyshev, B.S.,2 Tim Wood, Ph.D.,2 John Cuomo, Ph.D.,2
and James O. Hill, Ph.D.1

1Center for Human Nutrition, University of Colorado Denver, Denver, CO
2USANA Health Sciences, Inc., Salt Lake City, UT

Abstract
Objective: The objective of this study was to evaluate the effectiveness of an Internet-based 12-Week Healthy for Life Program in supporting weight loss and improvements
in metabolic and cardiovascular health among subjects with metabolic syndrome.
Research methods and procedures: Sixty subjects with metabolic syndrome were studied before, during, and after a 12-week online lifestyle intervention program that prescribed a low-glycemic diet, nutritional supplementation, and moderate exercise.

Results:

The intervention produced an average weight loss of 5.5 kg (5.4%). Measures of glycemic control improved significantly during the study. Fasting insulin was reduced by 32.3% and 120-minute insulin during an oral glucose tolerance test was reduced by 43.6%. Insulin sensitivity was increased as evidenced by a reduction in the homeostatic model assessment (HOMA) index (by 31.6%)and an increase in the insulin sensitivity index. There were also significant improvements in triglycerides, total cholesterol, and blood pressure.  At the end of the study, 58.5% of the study completers met criteria for the metabolic syndrome compared to 84.9% at baseline (p = 0.002).

Summary :

This study demonstrates than an online lifestyle change program that prescribes a low-glycemic diet,
nutritional supplements, and moderate exercise can successfully produce
meaningful weight loss, significant improvements in glycemic control, and significant reductions in risk factors for heart disease in individuals with metabolic syndrome.

Introduction

High rates of overweight and obesity in the United States

1 suggest that many Americans are at increased risk for several chronic diseases.

2 Most notably,overweight and obesity are often associated with a cluster of
risk factors for diabetes and cardiovascular disease.

These factors include a large waist circumference, elevated blood pressure, elevated triglycerides and fasting glucose, low high-density lipoprotein (HDL) cholesterol, and poor insulin
sensitivity. Individuals possessing several of these symptomsare now often diagnosed as having metabolic syndrome,3 a prediabetic state that recent research indicates may be reversible, in large measure through lifestyle change. Given the rising rates of type 2 diabetes, there is an urgent need to
develop lifestyle intervention programs for people with metabolic syndrome to prevent the progression of their disease.
Weight loss is an indicated treatment for both obesity and metabolic syndrome. Modest weight loss (5%–10% of initial weight) can improve cardiometabolic risk factors and reduce the risk of developing type 2 diabetes.4 The challenge lies in designing and providing programs that can effectively help the large numbers of people with metabolic syndrome to achieve modest weight loss. Several
approaches are available. In research settings, behavioral group treatment,5 individual treatment by counselors,5 meal replacement programs,5 and pharmaceutical interventions6
have shown some success. But given the large number of people who are overweight or obese, and/or who have metabolic syndrome, scale-up remains an issue. The Internet provides one means to easily and inexpensively deliver weight loss interventions to large numbers of people. That said, success to date in using this tool has been modest.7 The intent of this trial was to determine whether a 12-week, Internet-based lifestyle modification program prescribing a low-glycemic diet (including low-glycemic functional foods), vitamin and mineral supplements, and modest exercise could reduce body weight and improve symptoms related to the metabolic syndrome and cardiovascular risk.

Methods and Procedures
Participants
Male and female subjects with metabolic syndrome (defined as having abdominal adiposity combined with at least two other risk factors described below) were recruited from the Denver metropolitan area. All subject recruitment and selection was performed by University of
Colorado Denver, independently of USANA Health Sciences and The Healthy for Life Program. Eligible subjects were 20 to 60 years of age with a body mass index ! 42 kg/m2 and a waist circumference > 40 inches (males) or >35 inches (females). In addition, subjects had to have at least two of the following measurements at screening and/or baseline: elevated blood pressure (systolic > 130 mm
Hg and/or diastolic > 85 mm Hg); elevated triglycerides (> 150 mg/dL); elevated fasting glucose (> 100 mg/dL); or low HDL cholesterol (< 40 mg/dL for males, < 50 mg/dL for females). Participants also had to have access to e-mail and be willing to make changes to their diet and increase their activity level. Participants were excluded if they were pregnant or lactating, had been diagnosed
with type 2 diabetes or were taking medication for blood glucose control. Subjects on lipid-lowering medications, with allergies, or significant intolerance to soy foods or with acute or chronic illnesses that prevented participation in the study were also excluded. All participants provided informed written consent. The study protocol was approved by the Western Institutional Review Board (WIRB). Recruitment was via newspaper and email advertising; a telephone number was provided
for subjects to obtain more information and participate in a prescreening interview. Research staff prescreened 262 subjects via telephone. Of these, 80 subjects were screened in person, at which time data were obtained on weight, waist circumference, blood pressure, fasting blood lipids,
and fasting blood glucose. There were 20 screen failures, and 60 subjects were enrolled (24 males, 36 females).

Study Design
Enrolled subjects were asked to participate in a 12-week Healthy for Life Internet program that prescribed a low glycemic diet and modest exercise. They were providedwith vitamin and mineral supplements, low-glycemic meal replacement shakes, and nutrition bars as part of the prescribed diet (Table 1). Moreover, they were asked to keep an online food and physical activity diary for the
duration of the study. The following measurements were obtained at baseline,
week 6, and week 12: weight, waist circumference, blood pressure, and fasting blood measures of glucose, insulin, hemoglobin A1c (HbA1c) , serum triglycerides, total cholesterol, low-density lipoprotein (LDL) cholesterol, HDL cholesterol, high-sensitivity C-reactive protein, vitamin E (” and #), plasma-induced isoprostanes, and urinary isoprostanes. In addition, oral glucose tolerance tests were administered at each visit; pre- and post-glucose and insulin were obtained (at 0 minutes and 120 minutes,
respectively), and a finger-stick glucose was obtained at 90 minutes. Indexes of homeostatic model assessment (HOMA) and insulin sensitivity were calculated from these results.8,9 Subjects also completed the Food Craving Inventory10 at each visit. All data collection was
preformed independent of USANA Health Sciences by University of Colorado Denver staff.
Internet-based lifestyle change program The 12-week program was developed by a family practice
physician, and it was administered over the Internet. The Internet-based behavior modification program served two purposes: (1) to educate participants about the principles and practices of healthy lifestyle change and (2) to help hold participants accountable for adhering to the
recommended interventions. Participants received daily motivational and instructional e-mails that provided guidance in making healthy food choices and increasing physical activity. Participants
were also asked to make daily entries in their own online lifestyle journals, recording what they ate, how
they exercised, and whether they took their nutritional supplements. Lifestyle journals were reviewed weekly by a lifestyle coach who was then able to offer feedback and personalized guidance concerning program adherence. The coach was also available via e-mail to answer participants’
questions regarding the program. In addition, each participant received a copy of the book Healthy for Life, which described the lifestyle program and the principles of a low-glycemic diet in greater detail.11
Low-glycemic diet During the 12-week intervention period, subjects were
instructed to avoid high-glycemic foods that cause rapid rises in blood glucose, and instead to eat low-glycemic foods that cause modest but sustained increases in blood glucose. During the first 4 weeks, subjects were instructed to consume one low-glycemic meal replacement
shake for breakfast, another for lunch, two low-glycemic nutrition bars as snacks, and a low-glycemic dinner prepared according to instructions provided by the website. During the final 8 weeks of the study, subjects were instructed to consume one meal replacement shake for
either breakfast or lunch, and two low-glycemic meals again prepared according to instructions. They were also told to consume two low-glycemic snacks per day during this period; one nutrition bar and one snack of their choice. Throughout the study, subjects were told to take the prescribed vitamin/mineral supplements daily. The commercially available supplements, shakes and
bars were provided free of charge to the participants by USANA Health Sciences, the study sponsor. The
products are outlined in Table 1. Study participants also received $50 per study visit for a total of $200 compensation for participation in the study.

Changes in food cravings
Table 6 presents changes in scores on the Food Cravings Inventory (FCI) during the 12-week study. Both
FCI total scores as well as scores on each of the four subscales were reduced significantly during the 12-week intervention. Percentage of completers with metabolic syndrome measurements
Figure 1 illustrates the changes over the course of the study in percentages of completers for each of
the metabolic syndrome criteria and prevalence of the metabolic syndrome. At baseline, 84.9% of study
completers had three or more criteria defining the metabolic syndrome and at 12 weeks, 58.5% had three
or more criteria. The percentage of completers with elevated triglycerides at baseline was 60.4%. This
percentage decreased significantly to 45.3% at week 12. In addition, the percentage of completers meeting
the criteria for elevated blood pressure (>130/85 mm Hg) decreased from 79.3% at baseline to 43.4% at 12
weeks. Significant changes in the percentage of completers were not noted in the criteria for elevated waist
circumference, fasting glucose, or low HDL. Identical analyses were also performed for the 53
complete cases (participants who attended all three study visits: baseline, 6 weeks, and 12 weeks) and the results were similar to those reported using all available data.
Discussion
These results demonstrate that an Internet-based lifestyle change program can successfully produce meaningful weight loss in obese individuals with metabolic syndrome. The average weight loss was 5.4% and was associated with clear improvements in glycemic control and reductions in cardiometabolic risk factors. The 12-week Healthy for Life program was delivered via the Internet but involved using standard weight loss tools such as meal replacements, self-monitoring, behavioral change strategies, and low-glycemic diets. The results are significant in that they show the feasibility of using
standard tools delivered via an Internet format to achieve weight loss in obese individuals with metabolic syndrome. Given the need for strategies to help large numbers of obese individuals achieve weight loss, this is significant.Weight loss was not the only end point measured in this trial. On average, the 53 subjects who completed the study experienced improvements in many of the metabolic and
cardiovascular risk factors that were studied. Moreover, by the end of the study, the number of subjects who met the criteria for metabolic syndrome had dropped by one third, adding more support to the clinical significance of lifestyle modification in promoting overall health. A weakness of the present study was the absence of a no-treatment control group. However, given the natural
course of development of chronic disease, we think it is unlikely that a no-treatment control group would
have shown similar improvements. It will be important to continue to evaluate this online program and to compare it to a control group in the future. It will also be important to evaluate the long-term sustainability of the intervention. However, given the urgent need to develop
effective interventions that can easily be delivered to large numbers of people with metabolic syndrome, these results are promising.
Availability of programs and tools utilized in this research study The nutritional supplements (the USANA Essentials™) meal replacement shakes and snack bars used in this study
were provided by USANA Health Sciences, Inc.