Investigating Metabolic and Psychological Adaptations in a Clinical Trial (IMPACT)

University at Buffalo (UB)

Status: Active, not recruiting

Conditions: Obesity and Type 2 Diabetes

Treatments: Behavioral: Behavioral Skill Training; Other: Meal Provisioning

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06800794

1UM1TR005296-01 (U.S. NIH Grant/Contract)

STUDY00008988

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Woman between the ages of 18-45.
• Premenopausal.
• Obese (BMI ≥ 30).
• Diagnosed with prediabetes (HbA1c: 5.7%-6.4%).
• Experiencing food insecurity (score of 2-6 on the six-item food insecurity questionnaire).
• Income below 300% of the household federal poverty threshold.
• Lives alone.

Exclusion criteria

• Actively planning to become pregnant (e.g., individuals trying to conceive or undergoing fertility treatment, based on self-report).

• Delivered a baby within the past 6 months (self-report).

• Non-ambulatory (e.g., individuals unable to walk independently or requiring a wheelchair for mobility).

• Intellectual impairment that would impact treatment adherence.

• Unmanaged mood disorders, substance use disorders, personality disorders, or a history of eating disorders, including:

  • Generalized anxiety disorder.
  • Depression.
  • Alcohol dependence.
  • Schizophrenia.
  • Anorexia nervosa, bulimia, or binge eating disorder within the past 6 months.

• Recent weight loss exceeding 5% of body weight within the past 6 months (self-report).

• Food allergies to study-related foods, including dairy, soy, nuts, or gluten.

• History of bariatric surgery or GLP-1 agonist use (self-report).

• Inability to read or write in English (self-report).

• Planned relocation out of the study area during the study timeframe (self-report).

• Uncontrolled diabetes (HbA1c > 9%) or hypertension (blood pressure > 160/100 mmHg), based on self-report or screening visit measurements.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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12 participants in 2 patient groups

Control phase

No Intervention group

Description:

During this phase, participants are told to maintain typical behaviors and not change any normal patterns of activity/eating.

Treatment phase

Experimental group

Description:

There are two components to the treatment: Food provisioning: The food provisioning component will consist of bi-weekly home deliveries of three meals a day. The number of calories in the provided meals for each day will be personalized based on each participant's resting metabolic rate. Caloric targets for each participant will be 20% of TDEE as this translates to \~1-2 pounds of weight loss per week. Diets composition will also be tailored to help improve TEF and RQ. Behavioral Skills Training: This will be based on an evidence-based behavioral weight-loss program developed in our lab. This treatment has shown clinically significant weight loss with positive effects sustained over 10-years. The specific includes lessons on self-monitoring, developing alternatives to foods, meal-planning, goal setting, episodic future thinking, physical activity, and self-reinforcement.

Treatment:

Other: Meal Provisioning

Behavioral: Behavioral Skill Training