This study aims to explore how food insecurity, a lack of consistent access to enough food, may lead to changes in the body that make it harder to lose weight. The investigators are testing whether providing women experiencing food insecurity with a stable, healthy, and personalized meal plan can improve their metabolism and reduce their motivation to eat unhealthy foods. The hypothesis is that addressing food insecurity with a predictable diet can lower a person's respiratory quotient (a measure of how the body uses energy), promote fat burning, and improve overall health. This research will improve the understanding for how food insecurity contributes to obesity and may lead to better solutions for managing weight in individuals facing these challenges.
Women who experience food insecurity have unpredictable access to food and often miss meals and go hungry, but paradoxically are at a 50% greater risk for developing obesity than women who are food secure. This is due in part to metabolic and behavioral factors involved in food insecurity. Research suggests unpredictable access to food is associated with: 1) a high respiratory quotient (RQ) indicative of substrate oxidation that favors storage of fat and burning of carbohydrates; 2) an increase in fuel efficiency and a reduced thermic effect of food (TEF); 3) higher relative reinforcing efficacy of food (RREFOOD), due in part to periodic food deprivation that results from unpredictable access to food and being hungry, and 4) a short temporal window that involves making decisions that focus on meeting immediate versus long-term goals, as assessed by delay discounting (DD). While people with food insecurity and obesity should modify their diet, an RQ that favors storage of fat coupled with a reduced TEF, high RREFOOD and high DD may compromise the effects of traditional dietary approaches to weight loss. The goal of this pilot study is to examine the effects of providing a personalized, stable, predictable, low carbohydrate, low glycemic index, high protein, low energy dense diet on changes in metabolic and behavioral factors that characterize low-income women with food insecurity who have obesity, using a novel stepped wedge design. This work extends our research on behavioral and metabolic factors involved in food insecurity, and will provide strong pilot data for a randomized, controlled trial of a novel dietary approach that target factors involved in food insecurity and obesity that can improve weight control and reduce cardiometabolic risk factors. The investigators expect to screen at least 60 women, with an estimated screen failure rate of 80%. A goal for this pilot project is to provide effect sizes for future studies. The sample size was determined based on feasibility constraints, with the understanding that these results will serve as pilot data for a larger, fully powered randomized controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
12
7 sessions including: Hunger and fullness, eating on a budget, traffic light eating plan, menu planning, creating alternatives to food, financial planning, and changing the environment.
3 meals a day consisting of low energy dense, nutrient rich, ready to eat, low GI, foods delivered to the participants' homes.
Farber Hall G56
Buffalo, New York, United States
Change in body weight
measured in kgs using a weight scale.
Time frame: Through study completion, an average of 25 weeks
change in HBA1C
measured via a finger-prick blood sample analyzed using a point-of-care device
Time frame: Through study completion, an average of 25 weeks.
Change in respiratory quotient
will be measured in morning fasting state using the Breezing Pro, an FDA approved device for portable metabolic measures
Time frame: Through study completion, an average of 25 weeks.
change in TEF
will be measured in morning fasting state using the Breezing Pro, an FDA approved device for portable metabolic measures
Time frame: Through study completion, an average of 25 weeks.
Change in delay discounting
will be measured using the adjusting amount delay discounting task that presents participants with choices between a fraction of the total delayed amount of money now or the full amount ($100 \&/ $1000) at a future delayed time for five different periods from 30 days, 180 days, 365 days (1 year), 1095 days (3 years), 1825 days (5 years) (order randomized).
Time frame: Through study completion, an average of 25 weeks.
Change in RRE
RRE will be assessed through a survey that will use participants' preferred snack foods that are classified as either hyperpalatable or healthy. Scores have no fixed minimum or maximum, as they are determined by the highest ratio completed before the participant stops working for the food reward. Higher scores indicate greater reinforcing efficacy and a stronger motivational drive for the food reward, which is considered a worse outcome in this context.
Time frame: Through study completion, an average of 25 weeks.
change in stress
measured using the Perceived Stress Scale. The Perceived Stress Scale is a validated 10-item questionnaire that measures the perception of stress over the past month. Scores range from 0 to 40, where higher scores indicate greater perceived stress and worse outcomes.
Time frame: Through study completion, an average of 25 weeks.
change in physical activity
measured using a Fitbit activity monitor
Time frame: Through study completion, an average of 25 weeks.
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