Evaluating the implementation of a multi-level mHealth study to improve hydroxyurea utilization in sickle cell disease.

Background: Sickle Cell Disease (SCD) is a progressive genetic disease that causes organ damage and reduces longevity. Hydroxyurea is an underutilized evidence-based medication that reduces complications and improves survival in SCD. In a multi-site clinical trial, part of the NIH-funded Sickle Cell Disease Implementation Consortium (SCDIC), we evaluate the implementation of a multi-level and multi-component mobile health (mHealth) patient and provider intervention to target the determinants and context of low hydroxyurea use. Given the complexity of the intervention and contextual variability in its implementation, we combined different behavioral and implementation theories, models, and frameworks to facilitate the evaluation of the intervention implementation. In this report, we describe engagement with stakeholders, planning of the implementation process, and final analytical plan to evaluate the implementation outcomes. Methods: During 19 meetings, a 16-member multidisciplinary SCDIC implementation team created, conceived, and implemented a project that utilized Intervention Mapping to guide designing an intervention and its evaluation plan. The process included five steps: (1) needs assessment of low hydroxyurea utilization, (2) conceptual framework development, (3) intervention design process, (4) selection of models and frameworks, and (5) designing evaluation of the intervention implementation. Results: Behavioral theories guided the needs assessment and the design of the multi-level mHealth intervention. In designing the evaluation approach, we combined two implementation frameworks to best account for the contextual complexity at the organizational, provider, and patient levels: (1) the Consolidated Framework for Implementation Research (CFIR) that details barriers and facilitators to implementing the mHealth intervention at multiple levels (users, organization, intervention characteristics, broader community), and (2) the Technology Acceptance Model (TAM), a conceptual model specific for explaining the intent to use new information technology (including mHealth). The Reach Effectiveness Adoption Implementation and Maintenance (RE-AIM) framework was used to measure the outcomes. Discussion: Our research project can serve as a case study of a potential approach to combining different models/frameworks to help organize and plan the evaluation of interventions to increase medication adherence. The description of our process may serve as a blueprint for future studies developing and testing new strategies to foster evidence-based treatments for individuals living with SCD.

Measurement characteristics of dietary psychosocial scales in a Weight Gain Prevention Study with 8- to 10-year-old African-American girls.

Few measurement instruments for children's eating behaviors and beliefs have been specifically validated for African-American children. Validation within this population is important because of potential cultural and ethnic influences. Objectives were to evaluate established and newly developed or adapted dietary psychosocial measures in a sample of 303 preadolescent African-American girls and their caregivers. Acceptable internal consistency (Cronbach's alpha > or = 0.70) was found for measures of girls' self-efficacy for healthy eating, outcome expectancies for healthy eating, positive family support for healthy eating and household availability of low-fat food and fruit, juice and vegetables (FJV). Evidence for concurrent validity was found with significant associations between self-efficacy for healthy eating and lower intake of energy (r = -0.17) and fat grams (r = -0.16). Greater FJV availability was associated with greater FJV intake (r = 0.14) and lower body mass index (BMI) in girls (r = -0.12). Positive family support for healthy eating was associated with higher BMI in girls (r = 0.41). These results contribute to the development of scales to evaluate prevention interventions related to dietary intake in African-American children.

Health Opportunities with Physical Exercise (HOPE): social contextual interventions to reduce sedentary behavior in urban settings.

Physical activity interventions targeting social and physical environments of the urban poor hold promise in improving health outcomes in underserved communities. This study randomly assigned overweight, sedentary, economically disadvantaged adults to one of three intervention conditions at The Hope and Healing Center, a large inner-city health facility providing numerous options for exercise. Within the tenets of Social Action Theory, the Health Opportunities with Physical Exercise (HOPE) trial will test the efficacy of two behavior change models, social support and patient-provider interaction, to increase physical activity. In addition to a standard care condition, in which patients have open access to Hope and Healing physical activity programming, patients were assigned to one of two behavior change interventions. Those assigned to patient-peer receive face-to-face, systematic and scheduled encouragement from study-trained 'peer' interventionists at the facility. Patients assigned to patient-provider receive face-to-face, systematic and scheduled encouragement provided by study-trained 'provider' interventionists also at the facility. The primary outcomes of change in exercise behavior will be documented by self-reported physical activity and confirmed by fitness testing at baseline, 6, 12 and 24 months during the 1 year of active intervention and 1 year of relapse prevention follow-up. Intervention conditions will be compared on psychosocial mediators including motivational appraisals, ratings of social support, rapport, problem solving and self-efficacy for overcoming barriers to increased physical activity. Novel aspects of this intervention include: (1) delivery of socially based physical activity interventions to an economically disadvantaged urban population, (2) reduction of environmental barriers to be physically active and (3) emphasis on social interactions influencing health habit change. Results of this study have the potential to identify mechanisms of behavior change that could be adopted by physical activity interventions aimed at reducing sedentary behavior and health disparities in high-risk, underserved populations.

Smoking cessation in pregnant women.

Cigarette smoking is considered the most significant modifiable cause of adverse pregnancy outcomes in US women. Smoking cessation in pregnant patients is one of the most effective ways to reduce negative pregnancy outcomes of fetal growth retardation, preterm delivery, and perinatal mortality. Research evidence documenting the effectiveness of health care provider interventions in smoking cessation has led to the PHS recommendation to screen and counsel every patient. Materials from the PHS and NCI are available to assist health care providers in developing a brief office-based intervention. Patient materials for distribution are also available. Increased use of office-based cessation strategies, of cessation programs in community-based interventions, and of pharmacologic therapies is necessary to remedy the public health burden of fetal exposure to tobacco. Relapse prevention methods using office-based and social support systems are important to improve long-term maintenance of cessation in women who quit smoking during pregnancy.

Financial difficulty in acquiring food among elderly disabled women: results from the Women's Health and Aging Study.

OBJECTIVES: This study described the prevalence and characteristics of financial difficulty acquiring food and its relation to nutritional biomarkers in older disabled women. METHODS: Baseline data were analyzed from the Women's Health and Aging Study, a population-based survey of 1002 community-dwelling, disabled women 65 years and older from Baltimore, Md. RESULTS: Minority women (49.5%) were more likely than White women (13.4%) to report financial difficulty acquiring food (odds ratio [OR] = 6.2, 95% confidence interval [CI] = 4.5, 8.6). Of the women reporting financial difficulty acquiring food, only 19.3% received food stamps and fewer than 7% participated in food assistance programs. Women reporting financial difficulty acquiring food had higher levels of psychologic depression than women not reporting such difficulty. Greater likelihood of financial difficulty acquiring food was associated with poorer quality of life and physical performance among White women and with more medical conditions among minority women. Finally, anemia (hemoglobin < 120 g/L) was associated with financial difficulty acquiring food (age-adjusted OR = 2.9, 95% CI = 1.9, 4.3). CONCLUSIONS: Financial difficulty acquiring food was common, and receipt of nutritional services was rare, in community-dwelling, older disabled women. Nutrition assistance programs for the elderly should reexamine their effectiveness in preventing nutritional deficits in older disabled women.

Racial differences in adolescents' perceived vulnerability to disease and injury.

This study examined gender and racial differences in adolescents' risk perceptions of major diseases and motor vehicle injury and whether these perceptions agree with national mortality rates and parental health history. Adolescent (N = 135; 55% African-American) boys and girls reported on their chances compared to other adolescents of developing specific diseases or experiencing a motor vehicle injury and their knowledge of parental health history. Logistic regression models revealed that girls' risk perceptions were similar to boys' ratings even though females are at less risk than males per national figures. Caucasian adolescents inaccurately perceived that they were at significantly greater risk than African-American peers for motor vehicle injury, stroke, cancer, and heart attack. Adolescents' knowledge of a father's diabetes was predictive of greater perceived vulnerability to diabetes.

Relations of cigarette smoking and dietary antioxidants with placental calcification.

Associations between maternal cigarette smoking and accelerated placental maturation measured as tissue calcification have been reported. The authors sought to address whether intakes of the dietary antioxidants, vitamin C, alpha-tocopherol, and beta-carotene, were related to placental calcification of the maternal surface and villi in a cohort of smokers and nonsmokers at risk for delivering small-for-gestational age infants. Gross and histologic examination of placentas were used to determine calcification at the surface (n = 1,213) and villus sites (n = 730), respectively, in a prospective study of black and white women who delivered singleton births between December 1985 and October 1988 at the University of Alabama at Birmingham Hospital in Birmingham, Alabama. Controlling for race and gestational age, likelihood of surface and villus calcification increased as smoking levels increased. Significant reductions in villus calcification were related to alpha-tocopherol intake after controlling for smoking and gestation while intakes of beta-carotene and vitamin C were related to significant reductions in calcification for black but not white women. Surface calcification was not found to be related to antioxidant intake. The authors' findings confirm a pathologic relation between smoking and placental calcification and suggest that dietary antioxidants may reduce villus calcification.

Precision and estimated accuracy of two short-term food frequency questionnaires compared with recalls and records.

Two widely used food frequency questionnaires (Block FFQ, Willett FFQ) were modified to reflect intake over the past 7 days and compared to intake information gathered from diet records and 24-hr recalls covering the same 7-day period. The Block FFQ and the Willett FFQ were also gathered at the beginning of the assessment period to reflect the 7-day period of time before records and recalls were gathered. Fifty-six subjects were assigned to either recording diet for 3 days, recording diet for 6 days, or providing three 24-hr recalls. Results indicate similar levels of within-method test-retest reliabilities for 3-day RECORDS and 6-day RECORDS, and within the two Block FFQs and within the two Willett FFQs from each subject, while lower reliabilities were seen in 24-hr RECALLS. When the FFQs were compared to the 6-day RECORDS with between-method agreement coefficients, there was a moderate level of agreement, with most values between 0.5 and 0.8 for both FFQs. Significant differences between mean levels of nutrients estimated by the three methods indicated differences only in the estimates of carbohydrate and vitamin A. The use of FFQs to gather short-term intake information is discussed.

Predictors of waist circumference change in healthy young adults.

OBJECTIVE: To identify predictors of a change in waist circumference in a group of healthy young adults. SUBJECTS: Caucasian, 121 women and 109 men, participating in a longitudinal investigation of cardiovascular risk factors in parents and their young children. MEASUREMENTS: Evaluations of body weight, waist and hip circumferences, dietary intake, physical activity, cigarette smoking, and alcohol intake were performed annually. Age was recorded and family history of disease was assessed. RESULTS: For women, covariates and modifiable predictors accounted for 67% of the variance in waist circumference change from Year 1 to Year 3. Women with lower baseline waist girths, lower baseline hip girths, higher baseline body weight, and a greater change in body weight had larger increases in waist girth. For men, covariates and modifiable predictors accounted for 72% of the variance in waist circumference change. Men with lower baseline waist girth, a greater change in hip girth, higher baseline body weight, greater increases in body weight, and less percent of fat in the diet at baseline had larger increases in waist girth. Other non-modifiable variables did not predict change in either gender. CONCLUSION: Reducing excess body weight and decreasing weight gain appear to be the most important factors in preventing the accumulation of upper body fat.

Weight concerns and change in smoking behavior over two years in a working population.

The hypothesis that weight concerns are related to less successful smoking cessation and greater relapse among ex-smokers was prospectively evaluated. A population-based sample of 4981 working women and men 17 to 71 years of age was surveyed at 32 work sites. Current and previous weight loss efforts and smoking behavior were self-reported at baseline and 2 years later. Dieting and weight concerns were unrelated to smoking cessation or relapse. However, female smokers who had previously participated in a formal weight control program were three times more likely to quit smoking than those without a history of participation (25% vs 11%; odds ratio = 3.25, 95% confidence interval = 1.86, 5.67). Weight concerns and dieting efforts do not appear to inhibit smoking cessation or increase relapse in adults.

Effects of phenylpropanolamine on withdrawal symptoms.

A prior report (Klesges et al. 1990) suggested that phenylpropanolamine (PPA) was successful in reducing the smoking withdrawal symptom of weight gain in a sample of women. The current investigation evaluates whether the effects of phenylpropanolamine (PPA; up to 10/day PPA gums) on withdrawal symptoms associated with smoking cessation are specific to weight and weight-related symptoms or whether PPA alleviates withdrawal in general. One hundred and seven adult smokers (56 men, 51 women) were randomly assigned, in this double-blind trial, to chew either 8.33 mg phenylpropanolamine gum or a placebo gum. Subjects were then aided to quit smoking for 4 weeks. PPA did not enhance cessation rates. Results from the 47 subjects who successfully quit smoking indicated that postcessation weight gain and ratings of hunger were significantly reduced in both men and women for those assigned to the PPA group relative to the placebo group. Overall, no effects of PPA relative to placebo were observed for other smoking-related withdrawal symptoms. Thus, although PPA appears to reduce weight gain and alleviate weight-related symptoms, no effects on other withdrawal symptoms were observed. Future research directions are suggested.

Symptomatology across the menstrual cycle in smoking and nonsmoking women.

Recent studies suggest that both smoking rates and general menstrual symptomatology increase in women premenstrually; however, no study has investigated the changes in menstrual symptomatology and smoking behavior in both smoking and nonsmoking women over an entire menstrual cycle. Thirty premenopausal women completed daily symptom checklists over an entire menstrual cycle. Smokers also recorded their smoking behavior. Results indicated that symptom severity was greatest during menses for both smoking and nonsmoking women. For cigarette consumption, analyses indicated that women smokers appear to smoke more during menses and the luteal phases than ovulation and that variability in smoking was greatest premenstrually. In summary, results indicated that general menstrual symptomatology increases during menses and the late luteal phase and that smoking-deprivation symptomatology increase in both smokers and nonsmokers. This suggests that smokers may have a difficult time quitting during menses or the luteal phase of their cycle.

Relationship between obesity and the metabolic effects of smoking in women.

The influence of cigarette smoking on resting energy expenditure (REE) in normal-weight and obese smokers was investigated. Participants were 20 normal-weight and 20 obese female smokers assessed over a 2-day period. The results indicated that REE increased in both obese and normal-weight smokers after smoking, but the increase was greater for normal-weight participants. The normal-weight group showed a 9.7%, 5.8%, and a 3.6% increase in REE during the three 10-min blocks constituting the 30-min postsmoking phase. However, the obese group showed a 3.9% and a 0.7% increase in REE and a 0.8% decrease in REE during this postsmoking phase. Between-group comparisons revealed a differential rate of change in REE after smoking, indicating that the obese group's change of REE at every postsmoking time point was on average 70 kcal/day below that of the normal-weight group. The metabolic effect of smoking is reproducible, and the obese smokers reliably show an attenuated effect. However, the reliability of the change is lower for both normal-weight and obese smokers. The results have potential implications for discouraging obese persons from taking up smoking and intervening among those who already smoke.

A longitudinal analysis of accelerated weight gain in preschool children.

The purpose of the current investigation was to determine the dietary, physical activity, family history, and demographic predictors of relative weight change in a cohort of 146 children over a 3-year period. Results indicated that boys of normal-weight parents or who had only one parent overweight showed decreases in their body mass index (BMI) while those with two parents overweight showed increases. Girls with an overweight father showed BMI increases while others experienced decreases in BMI. Additionally, baseline intake of kilocalories from fat as well as decreases in fat intake were related to decreases in BMI. At higher levels of baseline aerobic activity, subsequent changes in BMI decreased. There was also a trend for changes in leisure activity--increases in children's leisure activity was associated with decreases in subsequent weight gain. Modifiable variables (ie, dietary intake, physical activity) accounted for more of the variance in changes in child BMI change than nonmodifiable variables (eg, number of parents obese). These results strongly suggest that encouragement of heart healthy dietary intake patterns and participation in physical activity can decrease accelerated weight gain and obesity, even in preschool children.

Effects of alcohol intake on resting energy expenditure in young women social drinkers.

This investigation evaluated the effects of alcohol consumption, controlled for the energy in alcohol and chronic effects of smoking, on resting energy expenditure (REE) in college-aged social drinkers. Sixteen women who both smoked and drank alcohol were administered, on 4 separate days in a counterbalanced order, 1) cigarettes alone, 2) alcohol alone, 3) alcohol plus cigarettes, or 4) cigarettes with an energetic control. Each session consisted of a 25-min REE baseline, treatment in a randomly assigned order, and a 105-min assessment of REE. Analysis indicated that alcohol significantly (P < 0.05) increased REE for up to 95 min after ingestion [increases of 29.6-68.4 kJ (124-287 kcal)/24 h], increases that could not be accounted for by the energy content of the drink alone. Smoking and alcohol together also raised REE above baseline but not more than alcohol alone. It was concluded that alcohol intake raises REE, potentially explaining why alcohol interferes with energy utilization. Potential implications for alcohol intake, nutrition, and weight loss are presented.

Caffeinated coffee and tea intake and its relationship to cigarette smoking: an analysis of the Second National Health and Nutrition Examination Survey (NHANES II).

Recent studies have shown that smokers' intake of caffeine is higher than nonsmokers. This investigation evaluated the relationships between smoking status and self-reported caffeine intake from both coffee and tea. Subjects were adults who participated in the Second National Health and Nutrition Examination Survey (NHANES II). Results indicated that subjects who ingested caffeine from tea were more likely to be female, less educated, younger, non-Caucasian, and lighter drinkers. In contrast, those who ingested caffeine from coffee were more likely to be older, Caucasian, heavier drinkers, and have higher incomes. Smokers were not more likely to drink caffeinated tea. In contrast, smokers were much more likely to drink caffeinated coffee, and a dose-response relationship between caffeine from coffee and smoking intake was observed. These results clarify the relationship between smoking and caffeine intake. Implications for intervention efforts are discussed.

The relationship between body mass and cigarette smoking using a biochemical index of smoking exposure.

This study evaluated the relationship between smoking and body mass using objective indices of both smoking exposure (COHb) and body mass. The subjects were 4240 adults who participated in the Second National Health and Nutrition Examination Survey (NHANES II). Measurements of dietary intake, physical activity, demographics, body mass index (BMI) and blood carboxy-haemoglobin (COHb) were used in these analyses. After controlling for covariables of body mass, the results indicated that smokers displayed a significantly lower mass compared with non-smokers. Smokers with higher levels of COHb had lower BMIs than smokers at lower COHb levels. White smokers had lower BMIs with increasing COHb exposure whereas black smokers had BMIs at high COHb exposure similar to those of non-smokers. Results indicated that smokers weighed less than non-smokers and that the weight control 'benefits' of smoking were most pronounced in white subjects who were heavy smokers.

Effects of television on metabolic rate: potential implications for childhood obesity.

The effects of television viewing on resting energy expenditure (metabolic rate) in obese and normal-weight children were studied in a laboratory setting. Subjects were 15 obese children and 16 normal-weight children whose ages ranged from 8 to 12 years. All subjects had two measured of resting energy expenditure obtained while at rest and one measurement of energy expenditure taken while viewing television. Results indicated that metabolic rate during television viewing was significantly lower (mean decrease of 211 kcal extrapolated to a day) than during rest. Obese children tended to have a larger decrease, although this difference was not statistically significant (262 kcal/d vs 167 kcal/d, respectively). It was concluded that television viewing has a fairly profound lowering effect of metabolic rate and may be a mechanism for the relationship between obesity and amount of television viewing.