Participants were encouraged to distribute their activity throughout the week with a minimum frequency of three times per week, with at least 10 min per session. A maximum of 75 min of strength training could be applied toward the total min weekly physical activity goal. The importance of lifestyle activities, such as using the stairs instead of elevators , stretching, and gardening, was discussed; however, participants were instructed not to apply these types of activities toward the min goal.
Participants at high risk for cardiovascular disease were given an exercise tolerance test before starting the activity interventions. Sedentary individuals were instructed to increase their activity in min increments over 5 weeks.
However, the physical activity goal was stated as a minimum, and participants who wished to be more active were strongly encouraged to do so, as long as there were no medical contraindications. The DPP primarily used an individual model of treatment, rather than a group-based approach, as had been used in many behavioral weight loss studies 12 , This decision was based on the extensive screening process and number of arms in the trial which limited the number of participants randomized to lifestyle each month and the desire to intervene before a participant had the possibility of developing diabetes or losing interest in the program.
The individual approach to therapy also allowed tailoring of intervention activities to the ethnically diverse population and those with low literacy. Adherence and maintenance activities included both individual and group approaches, based on the approaches used in the TONE trial The DPP was designed as a study of the efficacy of lifestyle changes in preventing or delaying diabetes.
Therefore, to maximize the possibility of achieving lifestyle change, an intensive approach to lifestyle was used throughout the trial. A large number of studies have been conducted to compare approaches to produce weight loss and increase physical activity and to maintain these behavior changes in the long term.
These studies were carefully reviewed and formed the basis for the development of the DPP intervention. To achieve standardization of the intervention, an initial structured core curriculum was given to all participants.
A more flexible maintenance program of individual sessions, group classes, motivational campaigns, and restart opportunities followed this. The lifestyle intervention commenced with a session core curriculum that was to be completed within the first 24 weeks after randomization. The session core curriculum was the most structured phase of the DPP lifestyle intervention and ensured that all participants were taught the same basic information about nutrition, physical activity, and behavioral self-management Table 2.
Similar to other state-of-the-art behavioral weight control programs, the first eight sessions presented the goals for the DPP lifestyle intervention, taught fundamental information about modifying energy intake and increasing energy output, and helped participants to self-monitor their intake and physical activity. The latter eight sessions focused on the psychological, social, and motivational challenges involved in maintaining these healthy lifestyle behaviors in the long term. Key behavioral and nutrition strategies that were introduced in the core curriculum included the following:.
Participants were weighed privately at the start of every individual session and were encouraged to weigh themselves at home daily or a minimum of once per week. If participants did not have a bathroom scale at home, they were given one. Emphasis was placed on using the scale as an important feedback and learning tool for how to better regulate personal diet and exercise behaviors.
The initial focus of the dietary intervention was on reducing total fat rather than calories. This allowed participants to accomplish a reduction in caloric intake while at the same time emphasizing overall healthy eating and streamlined the self-monitoring requirements, which was important given the diversity of educational and literacy levels among participants. After several weeks, the concept of calorie balance and the need to restrict calories as well as fat was introduced.
The fat and calorie goals were used as a means to achieve the weight loss goal rather than as a goal in and of itself. Therefore, if a participant reported consuming more than the calorie or fat goal but was losing weight as planned, the coach did not emphasize greater calorie or fat reduction.
Participants were encouraged to gradually achieve the fat and calorie levels through better choices of meals and snack items, healthier food preparation techniques, and careful selection of restaurants, including fast food, and the items offered.
All participants were instructed to self-monitor fat and calorie intake daily throughout the first 24 weeks of the study and to record their minutes of physical activity. Self-monitoring was stressed as one of, if not the most, important strategy for changing diet and exercise behaviors. At the start of the core curriculum sessions, participants were given a food scale and measuring cups and spoons. Self-monitoring skills were taught gradually over the first few weeks of the core curriculum.
The lifestyle coach briefly reviewed the self-monitoring booklets with the participants during each session, reinforcing any noticeable positive behavior change and avoiding criticism. The booklets were more thoroughly reviewed between sessions and written constructive comments were provided.
The maintenance program used in the DPP was more intensive than that used in other clinical trials 6 , 7 and combined both group and individual contact. After completing the session core curriculum, the protocol required that participants be seen face-to-face at least once every 2 months for the remainder of the trial and be contacted by phone at least once between visits. Although these in-person contacts were usually one-on-one, they could occur in a group as long as there was an opportunity to weigh the participant and assist the individual with problem-solving regarding adherence.
Based on behavioral literature showing the importance of continued contact during maintenance 23 , coaches were encouraged to meet with participants as often as needed to support participant adherence and transition gradually from more frequent to less frequent contact if decreased frequency of contact did not adversely affect maintenance.
The majority of participants were seen more frequently than the minimum, with some participants continuing to attend weekly or biweekly sessions. The Lifestyle Resource Core developed a variety of lessons and participant handouts, and lifestyle coaches were encouraged to use materials related to the topics of greatest interest and concern to their individual participants. Participants were encouraged to continue self-monitoring their intake for 1 week every month during maintenance.
If participants were succeeding at weight loss maintenance, self-monitoring was encouraged but not as strongly emphasized.
To simplify self-monitoring and encourage adherence to the calorie and fat goals, structured meal plans and meal-replacement products were provided as an option for participants. Each clinical center was also required to offer three group courses each lasting 4—8 weeks per year during the maintenance phase. Participants were strongly encouraged but not required to attend these classes. Popular classes included resistance training, vegetarian cooking, and restart programs for those desiring to re-initiate intensive weight loss efforts.
Three to four motivational campaigns were also developed per year to assist with maintenance of the weight and physical activity goals. In several campaigns, local participant teams or DPP centers competed for the best attendance, self-monitoring, weight loss, minutes of physical activity, or steps as measured by pedometer Accusplit Digi-Walker.
Participants received supplemental materials reflecting the content and theme of the campaigns such as self-monitoring postcards, magnets, weight graphs, newsletters, T-shirts, and other small incentives. The protocol required that each clinical center offer supervised physical activity sessions at least two times per week throughout the trial. Attendance was voluntary. The types of supervised activity sessions varied across centers and included neighborhood group walks, enrolling participants in the cardiac rehabilitation programs affiliated with the DPP clinical center, community aerobic classes e.
Methods: We performed a meta-analysis of prospective, randomised controlled trials RCTs that were identified in the medical literature and databases. Trials were eligible for inclusion if they reported all-cause mortality rates at a minimum , recruited approximately patients and had a minimum follow-up of one year.
Interventions were divided into pharmacological and non-pharmacological. You could not be signed in. Sign In Reset password. Sign in via your Institution Sign in via your Institution. Pay-Per-View Access. Buy This Article. View Metrics. Email alerts Article Activity Alert. Online Ahead of Print Alert. Latest Issue Alert. Twitter Facebook LinkedIn. Researchers met with participants individually at least 16 times in the first 24 weeks, and then every 2 months with at least 1 phone call between visits.
Metformin Group — Group participants took mg of metformin twice a day and were provided standard advice about diet and physical activity. Placebo Group — Group participants took a placebo twice a day instead of metformin and were provided standard advice about diet and physical activity.
DPPOS Results Year Findings At the year follow-up participants who took part in the DPP Lifestyle Change Program continued to have a delay in the development of diabetes by 34 percent—and developed diabetes about 4 years later—compared with participants who took a placebo.
Participants from the DPP Lifestyle Change Program ages 60 and older had a delay in the development of diabetes by 49 percent. However, the participants from the DPP Lifestyle Change Program achieved these results with fewer blood pressure and cholesterol-lowering medications. However, women from the DPP Lifestyle Change Program developed fewer small blood vessel problems than participants who continued to take metformin or took a placebo.
Participants who did not develop diabetes had a 28 percent lower rate of small blood vessel problems compared with participants who developed diabetes. There were some changes to the treatments each group received: Lifestyle Change Group —Group participants received quarterly group lifestyle change classes throughout the study and two group classes yearly to reinforce self-management behaviors for weight loss.
Metformin Group — Group participants received quarterly group lifestyle change classes throughout the study.
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