Challenges to recruitment and retention of African Americans in the gene-environment trial of response to dietary interventions (GET READI) for heart health.

In this paper, challenges to recruiting African Americans specifically for a dietary feeding trial are examined, learning experiences gained and suggestions to overcome these challenges in future trials are discussed. A total of 333 individuals were randomized in the trial and 234 (167 sibling pairs and 67 parents/siblings) completed the dietary intervention and required DNA blood sampling for genetic analysis. The trial used multiple strategies for recruitment. Hand distributed letters and flyers through mass distribution at various churches resulted in the largest number (n = 153, 46%) of African Americans in the trial. Word of mouth accounted for the second largest number (n = 120, 36%) and included prior study participants. These two recruitment sources represented 82% (n = 273) of the total number of individuals randomized in GET READI. The remaining 18% (n = 60) consisted of a combination of sources including printed message on check stubs, newspaper articles, radio and TV appearances, screening events and presentations. Though challenging, the recruitment efforts for GET READI produced a significant number of African American participants despite the inability to complete the trial as planned because of low recruitment yields. Nevertheless, the recruitment process produced substantial numbers that successfully completed all study requirements.

The "Rolling Store:" an economical and environmental approach to the prevention of weight gain in African American women.

OBJECTIVE: To test the feasibility of the "Rolling Store," an innovative food-delivery intervention, along with a nutrition education program to increase the consumption of healthy foods (fruits and vegetables) to prevent weight gain in African American women. METHODS: Forty eligible African American women were enrolled in the study and randomized to intervention or control groups. A trained peer educator and a Rolling Store operator implemented the study protocol at a local community center. RESULTS: The program retention rate was 93%. Participants in the intervention group lost a mean weight of 2.0 kg, while participants in the control group gained a mean weight of 1.1 kg at six months. Overall participants showed a mean decrease in weight of -.4 kg (standard deviation 3.0 kg), but the intervention group lost significantly more weight and had a decreased body mass index at six months. In the intervention group, the average number of servings consumed per day of fruits/ fruit juice and vegetables significantly increased at six months. CONCLUSIONS: The Rolling Store, at least on the small scale on which it was implemented, is a feasible approach to producing weight loss and improvements in healthy eating when combined with an educational program in a small community center.

Can individuals meet multiple physical activity and dietary behavior goals?

OBJECTIVES: To examine whether participants with the most behavioral goals to achieve were more likely to meet more goals than those given fewer goals. METHODS: Eight hundred ten participants were randomly assigned to advice-only, established guidelines for blood pressure control (reduced sodium, increased physical activity), or established guidelines plus the DASH diet (increased fruits, vegetables, low-fat dairy, reduced fat). RESULTS: At 6 months, 11.7% of Advice-Only, 19.3% of Established, and 44.6% of Established plus DASH met at least 3 goals (P<0.0001). At 18 months, 33.5% of Established plus DASH met at least 3 goals. CONCLUSIONS: Those with the most goals to achieve reached the most goals.

Comparison of strategies for sustaining weight loss: the weight loss maintenance randomized controlled trial.

CONTEXT: Behavioral weight loss interventions achieve short-term success, but re-gain is common. OBJECTIVE: To compare 2 weight loss maintenance interventions with a self-directed control group. DESIGN, SETTING, AND PARTICIPANTS: Two-phase trial in which 1032 overweight or obese adults (38% African American, 63% women) with hypertension, dyslipidemia, or both who had lost at least 4 kg during a 6-month weight loss program (phase 1) were randomized to a weight-loss maintenance intervention (phase 2). Enrollment at 4 academic centers occurred August 2003-July 2004 and randomization, February-December 2004. Data collection was completed in June 2007. INTERVENTIONS: After the phase 1 weight-loss program, participants were randomized to one of the following groups for 30 months: monthly personal contact, unlimited access to an interactive technology-based intervention, or self-directed control. Main Outcome Changes in weight from randomization. RESULTS: Mean entry weight was 96.7 kg. During the initial 6-month program, mean weight loss was 8.5 kg. After randomization, weight regain occurred. Participants in the personal-contact group regained less weight (4.0 kg) than those in the self-directed group (5.5 kg; mean difference at 30 months, -1.5 kg; 95% confidence interval [CI], -2.4 to -0.6 kg; P = .001). At 30 months, weight regain did not differ between the interactive technology-based (5.2 kg) and self-directed groups (5.5 kg; mean difference -0.3 kg; 95% CI, -1.2 to 0.6 kg; P = .51); however, weight regain was lower in the interactive technology-based than in the self-directed group at 18 months (mean difference, -1.1 kg; 95% CI, -1.9 to -0.4 kg; P = .003) and at 24 months (mean difference, -0.9 kg; 95% CI, -1.7 to -0.02 kg; P = .04). At 30 months, the difference between the personal-contact and interactive technology-based group was -1.2 kg (95% CI -2.1 to -0.3; P = .008). Effects did not differ significantly by sex, race, age, and body mass index subgroups. Overall, 71% of study participants remained below entry weight. CONCLUSIONS: The majority of individuals who successfully completed an initial behavioral weight loss program maintained a weight below their initial level. Monthly brief personal contact provided modest benefit in sustaining weight loss, whereas an interactive technology-based intervention provided early but transient benefit. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00054925.

PREMIER--a trial of lifestyle interventions for blood pressure control: intervention design and rationale.

Interventions encouraging adoption of healthy diets and increased physical activity are needed to achieve national goals for preventing and treating hypertension, cardiovascular disease, diabetes, and other chronic diseases. PREMIER was a multicenter clinical trial testing the effects of two lifestyle interventions on blood pressure control, compared with advice only. Both interventions implemented established national guidelines for blood pressure control (weight loss, reduced sodium and alcohol intake, and increased physical activity), and one intervention also included the Dietary Approaches to Stop Hypertension (DASH) diet. Both interventions focused on behavioral self-management, motivational enhancement, and personalized feedback. This article describes the design and evaluation approaches for these interventions. Evaluation of multicomponent lifestyle change interventions can help us understand the benefits and difficulties of making multiple lifestyle changes concurrently and the effects such changes can have on blood pressure, particularly in minorities at higher risk for hypertension.

Poverty and food intake in rural America: diet quality is lower in food insecure adults in the Mississippi Delta.

OBJECTIVE: To determine if measures of diet quality differ between food insecure and food secure adults in a rural high-risk population. DESIGN: Random digit dialing telephone survey of a cross-section of the population designed to collect data on food intake, household demographics, and food security status. SETTING: A representative sample of adults who live in 36 counties in the Lower Mississippi Delta region of Arkansas, Louisiana, and Mississippi. SUBJECTS: One thousand six hundred seven adults, both white and African American. MAIN OUTCOME MEASURES: Food security status and diet quality, as defined by adherence to the Healthy Eating Index and Dietary Reference Intakes by determinations from self-reported food intake (1 day intake). STATISTICAL ANALYSES: Regression analysis, t tests, Wald statistic, and beta tests were employed. RESULTS: Food secure adults scored higher on Healthy Eating Index than food insecure adults (P=0.0001), but the regression model showed no differences when multiple factors were included. Food secure individuals consistently achieved higher percentages of the Dietary Reference Intakes (specifically Estimated Average Requirements and Adequate Intakes) than food insecure individuals, with the greatest differences seen for vitamin A (P<0.0001), copper (P=0.0009), and zinc (P=0.0022) and very little difference for vitamins C (P=0.68) and E (P=0.32). Both populations consumed diets extremely low in fiber. CONCLUSIONS: Food insecurity is associated with lower quality diets in this population. It is acknowledged that serious limitations are associated with the use of one 24-hour recall and for comparison between food intake and assessment of food security. These findings still suggest a pressing need for nutrition interventions to improve dietary intake in these at-risk impoverished individuals.

Effects of comprehensive lifestyle modification on diet, weight, physical fitness, and blood pressure control: 18-month results of a randomized trial.

BACKGROUND: The main 6-month results from the PREMIER trial showed that comprehensive behavioral intervention programs improve lifestyle behaviors and lower blood pressure. OBJECTIVE: To compare the 18-month effects of 2 multicomponent behavioral interventions versus advice only on hypertension status, lifestyle changes, and blood pressure. DESIGN: Multicenter, 3-arm, randomized trial conducted from January 2000 through November 2002. SETTING: 4 clinical centers and a coordinating center. PATIENTS: 810 adult volunteers with prehypertension or stage 1 hypertension (systolic blood pressure, 120 to 159 mm Hg; diastolic blood pressure, 80 to 95 mm Hg). INTERVENTIONS: A multicomponent behavioral intervention that implemented long-established recommendations ("established"); a multicomponent behavioral intervention that implemented the established recommendations plus the Dietary Approaches to Stop Hypertension (DASH) diet ("established plus DASH"); and advice only. MEASUREMENTS: Lifestyle variables and blood pressure status. Follow-up for blood pressure measurement at 18 months was 94%. RESULTS: Compared with advice only, both behavioral interventions statistically significantly reduced weight, fat intake, and sodium intake. The established plus DASH intervention also statistically significantly increased fruit, vegetable, dairy, fiber, and mineral intakes. Relative to the advice only group, the odds ratios for hypertension at 18 months were 0.83 (95% CI, 0.67 to 1.04) for the established group and 0.77 (CI, 0.62 to 0.97) for the established plus DASH group. Although reductions in absolute blood pressure at 18 months were greater for participants in the established and the established plus DASH groups than for the advice only group, the differences were not statistically significant. LIMITATIONS: The exclusion criteria and the volunteer nature of this cohort may limit generalizability. Although blood pressure is a well-accepted risk factor for cardiovascular disease, the authors were not able to assess intervention effects on clinical cardiovascular events in this limited time and with this sample size. CONCLUSIONS: Over 18 months, persons with prehypertension and stage 1 hypertension can sustain multiple lifestyle modifications that improve control of blood pressure and could reduce the risk for chronic disease.

Effects of individual components of multiple behavior changes: the PREMIER trial.

OBJECTIVES: To assess contributions of individual lifestyle changes on systolic blood pressure (SBP) changes. METHODS: We examined associations between lifestyle behavior changes and SBP after 6 and 18 months in 782 PREMIER trial participants. RESULTS: In multivariate models omitting weight, predicted SBP reductions ranged from (1)/2 to 1(1)/2 mm Hg for reduced urinary sodium, improved fitness, and adherence to the DASH diet (except sodium at 18 months). With weight included, only fitness change additionally predicted SBP at 18 months. CONCLUSIONS: Several lifestyle behavior changes are important for BP lowering, but are difficult to detect when weight is included in multivariate models.

Energy expenditure and substrate oxidation predict changes in body fat in children.

BACKGROUND: The hypothesis that alterations in energy metabolism predict body fat gain is controversial. OBJECTIVE: The aim of this study was to determine which components of energy metabolism were most important in predicting fat gain in children aged 10.8 +/- 0.6 y. DESIGN: A 2-y longitudinal study to examine whether components of energy metabolism are predictors of body fat gain was conducted in 114 preadolescent African American and white children aged 9-11 y by measuring total daily energy expenditure on the basis of doubly labeled water (DLW), resting metabolic rate, the thermic effect of food, energy expended in physical activity, and substrate oxidation after a meal. The primary endpoint was the 2-y change in percentage body fat (%BF). RESULTS: Individual variables of energy metabolism predicted up to 7% of the variance in changes in %BF over the 2-y interval in the whole group. Predictors of change in body fatness tended to be sex and race specific. Protein oxidation during a test meal explained a significant portion of the variance in change in %BF in the overall group and in nearly all of the subgroups. Multivariate prediction models accounted for 10-41% of the variance in change in %BF. Tanner stage at 2-y follow-up was highly predictive of change in body fatness and improved the overall prediction, accounting for 24-62% of the variance in change in %BF in those groups in which Tanner entered the model. CONCLUSION: This study provides evidence that total daily energy expenditure, resting metabolic rate, substrate oxidation, and total energy intake are predictors of gain in body fatness during late childhood in boys and girls.

A pilot church-based weight loss program for African-American adults using church members as health educators: a comparison of individual and group intervention.

OBJECTIVE: The purpose of this study was to examine a church-based intervention employing a 6-month pilot weight loss program as a strategy to improve health of African-American adults. DESIGN: A randomized trial design was used without a control group. Eligible church members were randomized into two groups: an intervention delivered in the group setting and an intervention delivered in the individual setting. SETTING: The study was conducted at an African-American church in Baton Rouge, Louisiana. PARTICIPANTS: Forty church members were enrolled in the study. Two trained church members without specialization in obesity treatment conducted the study. MAIN OUTCOME MEASURES: The primary outcome measure was weight loss. RESULTS: The program retention rate was 90%. After six months, a modest but significant mean weight loss was seen in all participants of 3.3 kg. The mean weight losses in the individual and group interventions were 3.4 kg and 3.1 kg, respectively. The mean body fat loss was 2.1 kg and 1.9 kg, respectively. The difference in weight loss and fat loss between the individual and group interventions was not statistically significant. An improvement in the quality of life and an increase in physical activity were reported by the program participants. CONCLUSIONS: A church setting may provide an effective delivery mechanism for a health and nutrition program. Church members may be trained to conduct a weight control program. Both interventions (individual and group) were effective in inducing weight loss.

Baton Rouge Healthy Eating and Lifestyle Program (BR-HELP): A Pilot Health Promotion Program.

Preventing weight gain rather than treating recognized obesity is an important economic and public health response to the growing levels of obesity nationwide. Community centers offer potential sites for community health promotion programs targeting African Americans. In this article, results from a pilot health promotion program at a community center are reported. The purpose of this 12-month pilot program was to improve diet and increase physical activity to prevent weight gain in African-American adults by delivering a lifestyle intervention. Fifty-one African-American adults were randomized into two groups: lifestyle intervention or financial counseling, and 73% completed the program. At the end of 12 months, weight for all participants was maintained from baseline to completion with no significant differences between the groups. Both lifestyle intervention and financial counseling groups were approximately 87% food secure with improvements observed in self-esteem and total quality of life scores.

Energy expenditure in African American and white boys and girls in a 2-y follow-up of the Baton Rouge Children's Study.

BACKGROUND: Previously reported race and sex differences in energy expenditure (EE) may play a role in body fat gain. OBJECTIVE: The purpose of the study was to determine the relations between race, sex, Tanner stage, and EE. DESIGN: We conducted a 2-y follow-up study of EE in 114 African American (AA) and white girls and boys aged 12.7 +/- 0.1 y ( +/- SE), who were stratified as obese or lean and were part of the Baton Rouge Children's Study. Total daily EE (TDEE) was measured by using doubly labeled water. Resting metabolic rate (RMR) and thermic effect of food were measured by using indirect calorimetry. RESULTS: White children had significantly higher TDEE and RMR than did AA children when fat-free mass was considered. Boys had significantly higher TDEE and RMR than did girls, even after adjustment for differences in size. TDEE and RMR were significantly higher in obese children, as a result of their greater fat-free mass and body fat, than in lean children. Activity-related EE did not differ significantly between obese and lean children. There was a strong relation between initial and 2-y TDEE and RMR. There was a significant decrease in activity-related EE in both racial groups. AA children had significantly more lean limb mass than did white children. CONCLUSIONS: Average TDEE did not change over 2 y, but RMR increased significantly, and activity-related EE decreased significantly. Differences in trunk and limb lean mass of white and AA children may explain some of the ethnic differences in EE. The decrease in physical activity over 2 y may contribute to the risk of obesity.

Energy expenditure in preadolescent African American and white boys and girls: the Baton Rouge Children's Study.

BACKGROUND: Low energy expenditure has been identified as a potential risk factor for body fat gain. OBJECTIVE: The objective was to determine the relations between race, sex, body fat, and energy expenditure. DESIGN: As part of the Baton Rouge Children's Study, energy expenditure was examined in 131 preadolescent African American and white girls and boys, further stratified as obese or lean. Total daily energy expenditure (TDEE) was measured by the doubly labeled water method. Resting metabolic rate (RMR) and the thermic effect of food were measured by indirect calorimetry. Fat-free mass and fat mass were measured by dual-energy X-ray absorptiometry. To account for differences in body size, energy expenditure variables were adjusted with the use of fat-free mass or fat-free mass and fat mass as covariates. RESULTS: The African American children had lower TDEE and RMR than did the white children. A lower level of energy expended in physical activity by the African American girls and a lower RMR in the African American boys accounted for the racial differences in TDEE. The white boys had a higher RMR than did the white girls. The girls had a lower TDEE and expended less energy in activity than did the boys. Energy expended in activity was lower in the obese children. CONCLUSIONS: The African American children expended less energy than did the white children. The obese children spent less time engaged in activity or engaged in lower-intensity activity. Obese children may maintain their obese state by spending less time in physical activity, but they do not have a reduced RMR or thermic effect of food.

Prediction of body fat in 12-y-old African American and white children: evaluation of methods.

BACKGROUND: The prevalence of obesity is increasing in children. Validation of methods of predicting fatness in African American and white children could help to identify children at high risk. OBJECTIVE: We assessed published methods for determining body fat in 12-y-old male and female white and African American schoolchildren. DESIGN: The body fat of 114 children was measured with the use of dual-energy X-ray absorptiometry, underwater weighing (densitometry), measurement of skinfold thicknesses, isotope dilution (H(2)(18)O), and bioelectrical impedance analysis. Formulas derived from these data and from published reports were compared by using the Bland-Altman approach. RESULTS: Calculation of percentage of body fat by using an equation predicting body fat in kg and dividing by the current weight was the criterion method against which the other methods were compared. Four-compartment models had the smallest variability across the range of body fat, and 2 of these models differed from the criterion method by 1-2%. Six methods (the Pennington 4-compartment model, the Wells et al 4-compartment model, the isotope dilution model, dual-energy X-ray absorptiometry, the Pennington skinfold thickness model, and the Pennington density model) provided specificity > 90%, an estimate of body fat that was within the 95% CI of the criterion method, and a difference from the criterion method that was < +/- 2%. Bioelectrical impedance analysis was the least acceptable method. CONCLUSIONS: A 4-compartment model in which body fat in kg is divided by current body weight and multiplied by 100 provides the best estimate of percentage of body fat. The isotope dilution and body density models provide estimates within 2% of the estimate provided by the 4-compartment model. Other models do less well.

Premier: a clinical trial of comprehensive lifestyle modification for blood pressure control: rationale, design and baseline characteristics.

PURPOSE: To describe PREMIER, a randomized trial to determine the effects of multi-component lifestyle interventions on blood pressure (BP). METHODS: Participants with above optimal BP through stage 1 hypertension were randomized to: 1) a behavioral lifestyle (BLS) intervention that implements established recommendations, 2) a BLS intervention that implements established recommendations plus the DASH diet, or 3) an advice only standard of care group. The two BLS interventions consist of group and individual counseling sessions for 18 months. The primary outcome is systolic BP at 6 months. Additional outcomes include diastolic BP and homocysteine at 6 months; systolic and diastolic BP at 18 months; fasting lipids, glucose and insulin at 6 and 18 months; and effects in subgroup. CONCLUSION: Results from the PREMIER trial will provide scientific rationale for implementing multi-component behavioral lifestyle intervention programs to control BP and prevent CVD.

Comprehensive lifestyle modification and blood pressure control: a review of the PREMIER trial.

The PREMIER trial assessed the aggregate effect on blood pressure (BP) of nationally recommended lifestyle modifications in free-living adults with high-normal (stage 1) hypertension. Participants (N=810) were randomized to the advice-only group; the established group (consisting of weight loss, increased physical activity, and reduced sodium and alcohol intake); or the established plus Dietary Approaches to Stop Hypertension (DASH) diet group (consisting of the established interventions in addition to the DASH dietary pattern). The primary outcome was change in systolic BP at 6 months. Net of advice only, mean systolic BP declined by 3.7 mm Hg for members of the established group (p<0.001) and 4.3 mm Hg for the established plus DASH group (p<0.001). The prevalence of hypertension decreased from a baseline of 38% to 17% in the established group (p=0.01) and to 12% in the established plus DASH group (p<0.001) compared with a decrease to 26% in the advice-only group. The PREMIER trial demonstrated that persons with above-optimal BP and stage 1 hypertension can make multiple lifestyle changes leading to better control of BP.

People United to Sustain Health (PUSH): a community-based participatory research study.

The prevention of weight gain to address the obesity epidemic rather than weight loss involves promoting small changes in food choices and physical activity. People United to Sustain Health (PUSH) was designed to increase fruit and vegetable consumption, physical activity, and food security to prevent weight gain in rural adults. Forty-nine participants were randomized into a treatment group which received access to a "Rolling Store," nutrition education and physical activity, and a control group which received family coping classes. Forty-one (84%) of participants completed the study. At the end of 6 months, weight for all participants was maintained from baseline to completion with no significant differences between the groups. The mean fruit consumption over 6 months for the treatment group increased and was significantly greater than change in the control group (p = 0.01). This community-based participatory research study was considered successful because weight gain was prevented.

Effect of an environmental school-based obesity prevention program on changes in body fat and body weight: a randomized trial.

This study tested the efficacy of two school-based programs for prevention of body weight/fat gain in comparison to a control group, in all participants and in overweight children. The Louisiana (LA) Health study utilized a longitudinal, cluster randomized three-arm controlled design, with 28 months of follow-up. Children (N = 2,060; mean age = 10.5 years, SD = 1.2) from rural communities in grades 4-6 participated in the study. Seventeen school clusters (mean = 123 children/cluster) were randomly assigned to one of three prevention arms: (i) primary prevention (PP), an environmental modification (EM) program, (ii) primary + secondary prevention (PP+SP), the environmental program with an added classroom and internet education component, or (iii) control (C). Primary outcomes were changes in percent body fat and BMI z scores. Secondary outcomes were changes in behaviors related to energy balance. Comparisons of PP, PP+SP, and C on changes in body fat and BMI z scores found no differences. PP and PP+SP study arms were combined to create an EM arm. Relative to C, EM decreased body fat for boys (-1.7 ± 0.38% vs. -0.14 ± 0.69%) and attenuated fat gain for girls (2.9 ± 0.22% vs. 3.93 ± 0.37%), but standardized effect sizes were relatively small (<0.30). In conclusion, this school-based EM programs had modest beneficial effects on changes in percent body fat. Addition of a classroom/internet program to the environmental program did not enhance weight/fat gain prevention, but did impact physical activity and social support in overweight children.

Longitudinal study of body weight changes in children: who is gaining and who is losing weight.

Cross-sectional studies have reported significant temporal increases in prevalence of childhood obesity in both genders and various racial groups, but recently the rise has subsided. Childhood obesity prevention trials suggest that, on average, overweight/obese children lose body weight and nonoverweight children gain weight. This investigation tested the hypothesis that overweight children lose body weight/fat and nonoverweight children gain body weight/fat using a longitudinal research design that did not include an obesity prevention program. The participants were 451 children in 4th to 6th grades at baseline. Height, weight, and body fat were measured at month 0 and month 28. Each child's BMI percentile score was calculated specific for their age, gender and height. Higher BMI percentile scores and percent body fat at baseline were associated with larger decreases in BMI and percent body fat after 28 months. The BMI percentile mean for African-American girls increased whereas BMI percentile means for white boys and girls and African-American boys were stable over the 28-month study period. Estimates of obesity and overweight prevalence were stable because incidence and remission were similar. These findings support the hypothesis that overweight children tend to lose body weight and nonoverweight children tend to gain body weight.

Step-based translation of physical activity guidelines in the Lower Mississippi Delta.

To determine how many steps·day(-1) equate to current moderate-to-vigorous physical activity (MVPA) guidelines in a population from the Lower Mississippi Delta (LMD) of the United States, 58 overweight adults wore an Actigraph accelerometer (GT3X) for up to 2 weeks. Min·day(-1) in MVPA was a good predictor of steps·day(-1) (r(2) = 0.62; p < 0.001; linear regression), such that 30 min of daily MVPA equated to 9154 steps·day(-1) (mixed-model approach). Using receiver operating characteristic analysis, sensitivity and specificity were optimized at 8357 steps·day(-1). Results indicate that overweight residents of the LMD should be accumulating at least 8300-9100 steps·day(-1) to meet the recommendation of 30 min·day(-1) MVPA.