Intervening to Repair Neuropsychological Deficits in Adult Survivors of Severe Childhood Malnutrition
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cognition
研究概览
简要总结
Globally, in 2011, 52 million children under 5 years old suffered from acute malnutrition, and a further 165 million children showed evidence of chronic undernutrition or stunting. It was also estimated that 3.1 million children died in 2011 of malnutrition related causes. The survivors, due to deprivation of critical nutrients in the most important period of development and growth, are left with permanent damage, including an increased risk of cardio-metabolic disease, poorer educational achievement and diminished earning potential.
In Jamaica in 2012, 2.5% of children were moderately or severely underweight (more than two standard deviations below weight-for-age by international reference populations), falling from as high as 8.9% in 1993. Though there have been modest reductions in the incidence of acute malnutrition in Jamaica over the past 20 years, the risk remains high in poor families and among children who are being weaned. Hence, the problem is an ongoing one and we have a significant pool of survivors of childhood malnutrition who have now reached adulthood and face the consequences of early nutrient deprivation.
The brain is particularly vulnerable to the effects of malnutrition and studies have demonstrated both structural (brain atrophy) and functional (cognitive impairment and poor academic achievement) changes. This evidence, however, has been mainly in later childhood and adolescence. In addition, there is local data that suggests that cardio-metabolic risk factors are increased in these adult survivors, which are well-described precursors of cerebrovascular disease and cognitive impairment. Therefore, in adulthood there may be accelerated cognitive decline due to a poor cardio-metabolic profile superimposed on pre-existing brain injury.
We hypothesise that there are differences in cognitive function (poorer memory and executive function)and emotional responses in adult survivors of childhood malnutrition compared to those not exposed to early childhood malnutrition.
There is evidence suggesting that aerobic exercise and omega-3 supplementation have some benefit in reversing cognitive decline in older adults, but they have not been investigated in survivors of childhood malnutrition.Hence, we propose to introduce a six month intervention of supervised aerobic exercise and omega-3 supplementation, and will compare cognitive function pre and post intervention/placebo between malnutrition survivors and controls.
详细描述
This study will assess anthropometry, cardio metabolic profiles, cognitive and emotional domains between adult survivors of severe acute malnutrition (SAM) in childhood and healthy controls from similar communities, pre and post a six month intervention of supervised aerobic exercise and omega-3 supplementation.
Recruitment: The cases will include adult SAM survivors admitted to the University Hospital of the West Indies (UHWI) now between 20 and 55 years. They have been identified from UHWI records and traced using last known addresses by experienced field workers. Community controls will be recruited from the same communities, one per case and matched for sex, and age (within 5 years).
Sample Size Calculations: These are based on assessing differences in cognitive function using the NIH (National Institutes of Health) Toolbox Cognitive battery as the primary outcome measure between SAM survivors and community controls, and between pre-and post-intervention groups.
Using a test at the 5% level of statistical significance we will have 80% power to detect a difference of 2.8 √(2/n) standard deviations between cases and controls, where n=number of cases.
Therefore, at n=50, difference= 2.8 √ (2/50) = 0.56 SD
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The participant will be unaware of whether the capsules are supplement or placebo. The investigators will know that all persons in the exercise group will receive omega-3 supplements and that those not exercising will be receiving placebo capsules.
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •SAM survivors, both males and females and between the ages of 20 and 50 years
- •Community controls will be identified from the same street address as the cases and matched for sex, age ±5 years.
排除标准
- •Pregnancy
- •Unstable angina or myocardial infarction diagnosed within 3 months;
- •Heart failure (New York Heart Association category 2) or significant valvular dysfunction;
- •Peripheral arterial disease with claudication, major orthopaedic, chronic pain, or neuromuscular disorders restricting exercise;
- •Pulmonary or renal failure;
- •Poorly controlled hypertension (>190/110 mmHg) on two separate occasions, or type 2 diabetes mellitus, or type 1 diabetes mellitus regardless of control;
- •Recent hospitalisation for severe disease or surgery;
- •Regularly exercises at moderate or vigorous intensity for more than 30 minutes three times or more per week;
- •Is currently taking daily omega-3 supplements for over two weeks.
研究组 & 干预措施
Exercise and supplement
Supervised aerobic exercise three times weekly and daily omega-3 supplements
干预措施: Exercise plus omega-3 supplement (Combination Product)
Placebo
Olive oil capsules. No supervised exercise but written recommendations for daily physical activity from the American Heart Association
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Cognition
时间窗: Six months
NIH Toolbox Computerized Cognitive Battery
次要结局
- Emotional disturbances(Six months)